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

Model Number	8680204
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	12/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during bipolar prostate resection, the patient developed pulmonary embolism.The operation time was prolonged.However, the scheduled procedure was completed.The patient was kept in an emergency/hospital and was able to leave the hospital.
Additional Manufacturer Narrative
The active work element bipo 0/12/30°, type 8680204, batch 1511046 was investigated by (b)(6), and it was found that the rail of the conveyor is slightly bent.Otherwise, the working element shows normal signs of wear and the kv inspection is ok.This defect is due to mechanical overload.According to the latest information, an erbe vio 300 hf generator with a resection adapter was used during the procedure.However, there was no available information regarding the generator settings.There was no pump used, but a pocket irrigation/gravity process was administered.Furthermore, individual investigations of all richard wolf instruments used during procedure were performed to determine root causes.The optics 30° ø 3.3mm nl 299mm, type 8656422, sn (b)(6), was examined and found that the housing tube was bent on the housing.This caused the reversing lenses in the optical system to break.The glass breakage has contaminated the optics and severely obscured the view.This defect is due to mechanical overload.The outer shaft for resectoscope 26ch, type 8675426, batch 1532140, was inspected and it was found that the tube is bent and dented and that a stopcock is defective.This defect is due to mechanical overload.The internal shaft for resectoscope 24ch, type 8675324, batch 1393117, was inspected and it was found that the tube is bent, and the o-rings are slightly worn.This defect is due to mechanical overload.The working element active bipo 0/12/30°, type 8675324, batch 1394232 was inspected, and it was found that the rail of the transporter is slightly bent.The lock body is defective and therefore no electrodes can be locked.As a result, continuity testing and insulation testing are not possible.This defect is due to mechanical overload.The obturator for resektoskop 24ch, type 8673024, batch 1364719, was examined and it was determined that the mandarin bulb exhibits deep scratch marks.Otherwise, normal signs of wear.This defect is due to mechanical overload.The hook electrode bipo 22-26ch 12/30°, type 862309, batch 1373475, has been examined and it has been established that there is a severe proximal bend from the tube edge guide.This defect is due to mechanical overloading.The coagulation electrode bipo 22-26ch 12/30°, type 8623022, batch 1323872 has been examined, and it has been established that there is a severe proximal bend from the tubular edge guide.This defect is due to mechanical overloading.The cutting electrode bipo 24ch 12/30°, type 8622131, batch 21005187, has been examined and it was found that there is a severe proximal bend from the tube edge guide.This defect is due to mechanical overload.The cutting electrode bipo 24ch 12/30°, type 8622131, batch 21004647, has been examined and it has been determined that there is a severe proximal bend from the tube edge guide.This defect is due to mechanical overload.Results/conclusion of the richard wolf examination: based on the examinations described above, the cause of the incident can be attributed as a usage error.There is no apparent direct link to richard wolf products.In our view, the operating instructions ga-d342 / en / us / v11.0 / 2023-08 / pk23-0156 (in chapters 7, 8 and 9) contain sufficient information for the visual and functional check.The operating instructions refer to the checks to be performed at several points.Both the production records and the complaints database for the work element and the instruments used in the operation were checked.The records do not indicate production or batch defects.In risk assessment 86 r02, possible risks were considered with the corresponding extent of damage and the assumed probability of occurrence and assessed as an acceptable risk.This assessment remains valid even in the light of the current case.

• Brand Name: S-LINE
• Common Device Name: WORKING ELEMENT ACTIVE 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: heiko seider-biedermann ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 21403369
• Report Number: 9611102-2025-00004
• Device Sequence Number: 13090863
• Product Code: FDC
• UDI-Device Identifier: 04055207042922
• UDI-Public: 04055207042922
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2025

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
• Device Model Number: 8680204
• Device Catalogue Number: 8680.204
• Device Lot Number: 1511046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2022
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8622131, CUTTING ELECTRODE 24CH 12/30° LOT21004647; 8622131, CUTTING ELECTRODE 24CH 12/30° LOT21005187; 8623022, COAG ELECTRODE 22-26CH 12/30°L#1323872; 862309, HOOK ELECTRODE 22-26CH 12/30° LOT1373475; 8656422, OPTIK 30° Ø 3.3MM NL 299MM, SN (B)(6) ; 8673024, OBTURATOR-RESEKTOSCOPE 24CH LOT1364719; 8675324, INNER SHAFT-RESECTOSCOPE 24CH LOT1393117; 8675426, OUTER SHAFT-RESECTOSCOPE 26CH LOT153214; 8680204, WORK ELEMENT ACT BIPO 0/12/30° LOT1394232; ERBE VIO 300 HF GENERATOR
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male