Urgent Medical Device Recall

Transcription

1 PENTAX Medical 3 Paragon Drive Montvale, New Jersey Toll-free: Tel: Fax: June 12, 2014 Urgent Medical Device Recall Field Safety Corrective Action IFU Addendum for proper use of endoscopic accessories with; EG-3630U PENTAX Ultrasound Video Gastroscope EG-3830UT PENTAX Ultrasound Video Gastroscope EG-3870UTK PENTAX Ultrasound Video Gastroscope FG-36UX PENTAX Ultrasound Fiber Gastroscope Dear Valued Customer, PENTAX has initiated a Field Safety Corrective Action involving the Instructions For Use to clarify the method for advancing an accessory aspiration needle in the PENTAX Ultrasound Gastroscopes identified above distributed between June 1997 and May Issue PENTAX has been notified by two French physicians of a concern regarding a potential risk related to the use of the Ultrasound Gastroscopes with an accessory elevator (EG-3630U, EG-3830UT, EG-3870UTK, and FG-36UX) in combination with aspiration needles. There were no injuries reported by the physicians in either case. If the Instruction For Use are not followed carefully by the user and if the user fails to properly position the elevator while advancing the aspiration needle through the endoscope, the needle can get derailed from the elevator (as shown in the picture below). This could result in the needle not being visible in the endoscopic field of view or in the sonographic field of view. This could subsequently result in a potential risk to health for the patient, such as a perforation. The aspiration needle is "derailed" from the elevator. Figure 1 Page 1 of 5

2 PENTAX Medical 3 Paragon Drive Montvale, New Jersey Toll-free: Tel: Fax: Instructions The instructions specific to the use of PENTAX Ultrasound Gastroscopes (EG-3630U, EG-3830UT, EG-3870UTK, and FG-36UX) in combination with endoscopic accessories have been updated to include additional figures, cautions, and warnings to aid in the proper method for advancing the endoscopic accessory into the field of view. See attached Addendum to the Instructions for Use (IFU). We are asking all users to read and carefully follow the attached addendum in order to properly operate the PENTAX Ultrasound Gastroscopes in combination with endoscopic accessories. Failure to follow the addendum may result in possible injury to patients. Please ensure to update the endoscope IFU s identified below which were originally supplied with the endoscope at the time purchase: EG-3630U PENTAX Ultrasound Video Gastroscope IFU Part Number Z258 EG-3830UT PENTAX Ultrasound Video Gastroscope IFU Part Number Z258 EG-3870UTK PENTAX Ultrasound Video Gastroscope IFU Part Number Z845 FG-36UX PENTAX Ultrasound Fiber Gastroscope IFU Part Number Z166 Enclosed with this letter is a field correction response form. The form identifies the affected units which have been consigned (purchased, loaned, leased). Please forward this letter, the Addendum to the Instructions for Use, and the response form to the relevant Department(s) in your facility so that they may review the information provided and complete the response form. This recall is being made with the knowledge of the Food and Drug Administration. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately. Contact Information If you have any questions regarding this action please feel free to contact Paul Silva, Recall Coordinator at Tel: ext 2064 (8:30am 5:00pm, Monday Friday, EST) Fax: paul.silva@pentaxmedical.com Sincerely, Paul Silva PENTAX of America Inc. Director of Regulatory Affairs Page 2 of 5

3 Model: EG-3630U A01013 E E E E A01017 E E E E A01022 E E E E A01025 E E E E A01026 E E E E A01028 E E E E A01029 E E E E A01031 E E E E A01033 E01037 E E E A01036 E01038 E E E E E01039 E E E E E01042 E E E E E01043 E E E E E01046 E E E E E01054 E E E E E01061 E E E E E01062 E E Model: EG-3830UT E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E E Page 3 of 5

4 Model: FG-36UX A01014 A01049 A01079 A01100 A01166 A01019 A01053 A01080 A01104 A01168 A01020 A01054 A01081 A01105 A01174 A01029 A01055 A01082 A01116 A01183 A01030 A01056 A01084 A01122 A01184 A01033 A01057 A01086 A01126 A01186 A01036 A01068 A01092 A01131 A A01040 A01070 A01096 A01137 A A01046 A01074 A01098 A01142 Model: EG-3870UTK A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A Page 4 of 5

5 Model: EG-3870UTK (continued) A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A A Page 5 of 5