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

Model Number	8384.423
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf (b)(4).A follow up report will be submitted when new information becomes available.
Event or Problem Description
The user describes the incident and the consequences for the patient as follows: during lap cholecystectomy at electro coagulation in liver bed (bleeding control) isolation defect 2nd degree burn of skin (about 2cm²) at trocar in medioclavicular line below right costal arch.
Event or Problem Description
Please see manufacturers narrative for product evaluation.
Additional Manufacturer Narrative
The purpose of this report is to provide fda with missing, new and changed information as well as the product evaluation report.Device evaluation: the affected hook electrode electrode was visually inspected by the sales representative in the user facility, however the product was not sent back for further investigation there was damage to the insulation of the hool electrode in the upper shaft area.Furthermore, the affected hook electrode was probably inspected and/or repaired by a third-party company in (b)(6) 2020, there is an evidence in the upper shaft area: a marking "ncm/10/20".The material of the insolation probably no longer matches the specifications.Due to a third-party repair, the hook electrode is no longer a product of the company richard wolf gmbh.Since the incident was caused by a product that was probably repaired by an unauthorized company, the incident has no effect on the risk assessment and the risk assessment "b2-1 rev.04 - reusable electrode" remains valid.Richard wolf gmbh(rwgmbh) 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 corporati-on(rwmic) submitting report on behalf of rwgmbh report on behalf of rwgmbh.

• 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: 11979362
• Report Number: 9611102-2021-00023
• Device Sequence Number: 3673602
• Product Code: GEI
• UDI-Device Identifier: 04055207015278
• UDI-Public: 04055207015278
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/05/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8384.423
• Device Catalogue Number: 8384.423
• Device Lot Number: 1425593
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TROCAR
• Outcome Attributed to Adverse Event: Other