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

Model Number	8383423
Medical Device Problem Codes	Overheating of Device (1437); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Gastroesophageal Burn (4475); Insufficient Information (4580)
Date of Event	12/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 8383423 hook electrode mono ø 5mm wl 340mm has been in the programme since (b)(6) 1993.The batch 1498742 was booked with a total quantity of 80 pieces on the new goods stock on 01/19/2022.From this batch the following deliveries were made to our subsidiary in france: (b)(6) 2022: 6 pieces.(b)(6) 2022: 3 pieces.According to the production protocol, no abnormalities are known for this batch.So far, no complaints are known for this batch.As soon as the examination is completed, a follow-up report will be submitted to provide further information.
Event or Problem Description
Richard wolf gmbh reference: (b)(4).Richard wolf gmbh in knittlingen (manufacturer) was informed about the following: description of incident/claim according to the customer: "during surgery (laparoscopy for cholecystectomy), melting of the sheath which generated an accidental burn on the stomach." the instrument was replaced and the treatment could be completed.Rwgmbh mdr awareness date: 05-dec-2022.
Additional Manufacturer Narrative
Follow-up report #1 is to provide fda with the results of the device investigation.The examination of the returned hook electrode revealed that the insulation was distally burnt and melted.A laser mark was burnt into the insulation at the proximal end of the electrode shaft, which indicates a repair by an unauthorized third-party company.The electrode therefore does not correspond to the specifications given by richard wolf gmbh (rw gmbh) and it can be ruled out that the electrode was delivered in this condition.In the instructions for use of the product, this is explicitly prohibited in several warnings.(ga-s010 / en / 2019-09 v8.0 / pk19-9596): important general notes and instructions make sure that this product is used only as intended and described in this instruction manual, by adequately trained and qualified medical personnel, maintenance and repair must be carried out by authorized experts.Use the product only in the combinations and with the accessories and spare parts specified in this instruction manual.Use other combinations, accessories and replacement parts only if they are expressly intended for the planned application and if the performance characteristics and safety requirements are met.The product must not be altered in any way.Due to the third-party repair, the manufacturer richard wolf gmbh no longer considers this to be his product.
Event or Problem Description
Richard wolf gmbh reference: (b)(4).The purpose of this submission is to report the results of the device evaluation.See h10.Rwgmbh follow-up mdr awareness date: 28-dec-2022.

• Brand Name: NA
• Common Device Name: HOOK ELECTRODE MONO Ø 5MM WL 340MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; 75438, knittlingen, germany ; GM
• Manufacturer Contact: philipp schmidt ; pforzheimer strasse 32; 75438 knittlingen, germany ; GM
• MDR Report Key: 16026822
• Report Number: 9611102-2022-00062
• Device Sequence Number: 7224532
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 8383423
• Device Catalogue Number: 8383.423
• Device Lot Number: 1498742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2022
• Supplement Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2022
• 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
• Patient Sex: Unknown