MAUDE Adverse Event Report: RICHARD WOLF GMBH; HOOK ELECTRODE MONO

Model Number	8383.423
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Bowel Burn (1756)
Date of Event	05/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of this complaint is currently in progress.A follow up report will be submitted after the device evaluation or product history (if device not returned) has been completed and/or additional information become available.Rwmic is submitting this report on behalf of richard wolf (b)(4).
Event or Problem Description
Per rw (b)(4), the user describes the incident and the consequences for the patient as follows: "hook stripped of its protective shealth on 1mm, causing an electric burn of the small intestine on a patient.".
Additional Manufacturer Narrative
Follow-up report #1 is to provide fda with missing information, new information, and changed information and also provide the results of the device investigation.Results of the device investigation: according to the investigation, the affected device was repaired by an unauthorized third-party company.The plug contains a screw which is not part of the defined material list.The characteristics of the original device were changed.Because we've identified a component not in the bill of materials, there may be other components we've not identified that may have contributed to the malfunction.Richard wolf gmbh considers this matter closed.However, in the event rwgmbh receives any additional information a follow up report will be submitted to fda.Richard wolf medical instruments corporation(rwmic) submitting report on behalf of rwgmbh report.
Event or Problem Description
The purpose of this report is to report the results of the device investigation, see manufacturers narrative at the end.

• Brand Name: NA
• Common Device Name: HOOK ELECTRODE MONO
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 11983731
• Report Number: 9611102-2021-00024
• Device Sequence Number: 19097872
• Product Code: GEI
• UDI-Device Identifier: 04055207015001
• UDI-Public: 04055207015001
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K964329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: Health Professional
• Device Model Number: 8383.423
• Device Catalogue Number: 8383.423
• Device Lot Number: 1373173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 08/05/2021
• 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