MAUDE Adverse Event Report: RICHARD WOLF GMBH; HOOK ELECTRODE Ø 5MM WL 340MM

Model Number	8383423
Medical Device Problem Codes	Material Disintegration (1177); Material Fragmentation (1261)
Health Effect - Clinical Code	Gastroesophageal Burn (4475)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).According to the production control plan, there was no abnormailty from the affected lot.So far, no other hook electrodes from the affected lot have been returned to richard wolf (b)(4).As soon as the electrode has been sent in by the user, the investigation will be started.Rw (b)(4) considers this mdr open.A follow up report will be submitted when new information becomes available.
Event or Problem Description
It was reported to richard wolf: coagulatory hook with deteriorated sheath upstream of the work area, resulting in unwanted thermal burning of the stomach.So the surgeon twisted the sheath.Consequences for the patient, the user or other person: unwanted thermal burning of the stomach.
Additional Manufacturer Narrative
Follow-up report #1 is to provide fda with new information and changed information.New information: see below for results of the device investigation (h10).Changed information: the following fields have changed information: d10, e4, h2, h3.The results of the device investigation: according to the manufacturer, "the affected device was repaired by an unauthorized third-party company.The isolation and plug have been changed and do not meet the specifications and characteristics of the original device.Since the incident was caused by a device that was probably repaired by an unauthorized third-party company, the affected hook electrode may not meet the defined specifications.Therefore, the incident has no effect on the risk assessment and the risk assesment "b2-1, rev.04 reusable electrode" remains valid." 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 submission is to report the results of the device investigation.See manufacturers narrative.

• Brand Name: NA
• Common Device Name: HOOK ELECTRODE Ø 5MM WL 340MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• MDR Report Key: 12598689
• Report Number: 9611102-2021-00034
• Device Sequence Number: 3421461
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2021

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: 8383423
• Device Catalogue Number: 8383.423
• Device Lot Number: 1255851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown