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

Model Number 892101254

Device Problems Bent (1059); Break (1069); Poor Quality Image (1408); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 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.

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 Description

Follow up #1.

• Brand Name: DISCOSCOPE, 25 DEGREE, 6.9MM SL, 207MM
• Type of Device: ENDOSCOPE
• Manufacturer (Section D): RICHARD WOLF GERMANY (GMBH); registration #9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 6198752
• MDR Text Key: 63102520
• Report Number: 9611102-2016-00018
• Device Sequence Number: 1
• Product Code: GCM
• UDI-Device Identifier: 04055207035054
• UDI-Public: 04055207035054
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/25/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other