MAUDE Adverse Event Report: RICHARD WOLF GERMANY (GMBH) DISCOSCOPE, 25 DEGREE, 6.9MM SL, 207MM; ENDOSCOPE

Model Number	892101254
Medical Device Problem Codes	Bent (1059); Break (1069); Poor Quality Image (1408); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Actual device returned to manufacturer on 12/13/2016.Investigation/evaluation currently in process.(b)(4) considers this report open, follow-up report to be submitted once investigation is complete.(b)(4).Evaluation of device inprocess.
Event or Problem Description
Richard wolf (b)(4) was notified surgery was stopped while using device in question.The reason for stopping procedure is unknown at this time.Facility has been contact requesting additional information regarding the event, no response as of 12/22/2016.
Additional Manufacturer Narrative
Follow up #1 device was manufactured august 2016 and lot consists of (b)(4) units.Device in question sold to customer on 21sep2016.Inspection of the device found sheath was bent and contained a dent approximately 65mm from distal end.Inside of the device, at the dent location, broken glass lens was found.Moisture also entered the optical system resulting in picture deterioration.In our opinion, damage to sheath was due to mechanical overload.A product or manufacturing problem is not recognizable.The instructions for use (ifu) contains multiple visual and functional checks in order to identify issues early.Leaks that appear in optics system show up in the form of image deterioration and are usually found during instrument processing, and device should not be placed in use.In addition, the product must be inspected immediately before and after use for damage, loose and/or missing parts.The risk assessment, a1 r04, was reviewed and rated with an acceptable risk.This rating is still valid considering the current case.Richard wolf (b)(4) considers this matter closed.However, in the event richard wolf (b)(4) receives any additional information a follow up report will be submitted to fda.Richard wolf medical instruments corporation (rwmic) submitting report on behalf of richard wolf (b)(4).
Event or Problem Description
Follow up #1.

• Brand Name: DISCOSCOPE, 25 DEGREE, 6.9MM SL, 207MM
• Common Device Name: ENDOSCOPE
• Manufacturer (Section D): RICHARD WOLF GERMANY (GMBH); registration #9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 6198752
• Report Number: 9611102-2016-00018
• Device Sequence Number: 730085
• Product Code: GCM
• UDI-Device Identifier: 04055207035054
• UDI-Public: 04055207035054
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 892101254
• Device Catalogue Number: 89210.1254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2016
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/25/2016
• Supplement Date Received by Manufacturer: 11/25/2016
• Initial Report FDA Received Date: 12/22/2016
• Supplement Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other