MAUDE Adverse Event Report: RICHARD WOLF GMBH S-LINE; WORKING ELEMENT PASSIVE BIPO 0/12/30°

Model Number	8680225
Medical Device Problem Codes	Sparking (2595); Electrical Shorting (2926)
Health Effect - Clinical Codes	Burn(s) (1757); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility representative has informed richard wolf gmbh an issue regarding a working element passive bipo 0/12/30°, part id: 8680.225, batch # 1474987.The user facility claimed that "during a surgical procedure of transurethral resection of the prostate (turp), when activating the cutting function on the erbe electrosurgical scalpel, the working element occurred a short and sparked, thus burning the surgical instrument part id: 8680.225 s/n: (b)(4).Used electrodes: ref: 4622.1313 lot: 1492598 and ref: 4623.0223 lot: 4500358239.".Additional information from the user facility was received on 18/oct/2022: "it was not possible to verify exactly where the fire started due to the speed of the event and the tension of the moment, but the doctor's hand burned".
Additional Manufacturer Narrative
The reported devices were not returned for investigation.On the provided image of the working element passive bipo 0/12/30°, no electrical flashover can be seen.Also, the user facility has provided the used erbe hf generator setting: effect 8 for bipolar soft.The recommended setting for biolar soft is effect 4.No information was provided about the used hf cable.It is possible that the event was caused by the plug connection or by the hf cable.The working element passive bipo 0/12/30° 8680225, batch # 1474987 was manufactured on 20/apr/2021.The batch consisted of (b)(4) pieces.No issues were identified during production and no further complaints were received from the reported batch.The device history records of the used electrodes were also reviewed: the cutting electrode bipo 24fr 12/30° 46221313, batch # 1492598 was manufactured on 20/jan/2022.The batch consisted of (b)(4) pak of (b)(4) pieces.No issues were identified during production and no further com-plaints were received from the reported batch.The coag electrode bipo 24-26fr 12/30° 46230223, batch # 4500358239 was manufactured on 04/feb/2022.The batch consisted of (b)(4) pak of (b)(4) pieces.No issues were identified during production and no further complaints were received from the reported batch.The ifu ga-d342 / en-us / 2020-10 v9.0 / pk20-0319 contains several description of visual and functional checks which serve to detect faults prior to use on patient on section 7 checks.In addition, the ifu states the safety notice about service life of the device in section 8.6 reprocessing procedure.The subject issue of failure due to combination / setting errors of the system is present in the risk management file b6 - reusable optical working elements, 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: S-LINE
• Common Device Name: WORKING ELEMENT PASSIVE BIPO 0/12/30°
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 16582857
• Report Number: 9611102-2023-00019
• Device Sequence Number: 20087243
• Product Code: FDC
• UDI-Device Identifier: 04055207042953
• UDI-Public: 04055207042953
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/21/2023

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: 8680225
• Device Catalogue Number: 8680.225
• Device Lot Number: 1474987
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MODEL: 4622.1313 CUTTING ELECTRODE, LOT: 1492598.; MODEL: 4623.0223 COAG ELECTRODE, LOT: 4500358239.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown