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

Model Number	8383423
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility has informed richard wolf gmbh an issue regarding a hook electrode mono ø 5mm wl 340mm, part id: 8383423, batch # 1460860.According to the received information: "surgery: laparoscopy for acute cholecystitis monopolar current at 30 all the time of the intervention - hemostasis made with bipolar forceps not resulting from an excessive monopolar current.Incident: during the intervention, observation of a missing part, which probably fell into the patient, without it being formally found (perhaps sucked up during washing).No visible injuries but still a fear that the missing part of the hook was not aspirated during the intervention and therefore remained in the patient.No other consequences.".
Additional Manufacturer Narrative
New information: b4, d8, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h7, and h10.Corrected data: h4 the hook electrode mono ø 5mm wl 340mm 8383423, batch # 1460860 was examined in accordance with the test instructions.The device has signs of non-authorized third-party repair.Due to the non-authorized third-party repair, it is not possible to determine the root cause of the incident, since the device does not meet the specifications of richard wolf gmbh anymore.The hook electrode mono ø 5mm wl 340mm 8383423, batch # 1460860 was manufactured on 08/sep/2020.The batch consisted of 80 pieces.No issues were identified during production.No further complaints were received with the similar device issue neither from the same batch nor from another batch.In the relevant ifu ga-s 010 / usa / 2013-12 v4.0/ eco 2013-0468 contains safety notes regarding the repair at the beginning of the ifu as well as in section 8 checks.The subject issue of broken parts is present in the risk assessment file b2: reusable electrodes, rev.: v00.The overall probability of occurrence for this issue remains at previously defined levels and overall risk of the device remains in the acceptable category.

• 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; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: zsófia bartholome-nagy ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 16694005
• Report Number: 9611102-2023-00024
• Device Sequence Number: 20315946
• 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,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2023

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: Health Professional
• Device Model Number: 8383423
• Device Catalogue Number: 8383.423
• Device Lot Number: 1460860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2020
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown