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

Model Number	8680225
Medical Device Problem Code	Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The working element passive bipo 0/12/30°, part id: 8680.225, lot # 1546598, was checked by the technical department at richard wolf gmbh.The following fault was found in the lock housing, "electrical continuity interrupted".Due to the age of the working element, approx.10 months at time of the event, and the fault pattern (contamination in the clamping sleeve), we can attribute this fault to cleaning/maintenance errors.The complaint data research of the last 3 years has shown that there are three complaints including this complaint (b)(4) with a similar fault regarding maintenance and care.The instructions for use ga-d342 / en / us / v11.0 / 2023-08 / pk23-0156 (rw: en / 2021-03 v16.0 / pk20-0295) contain several safety instructions and information on reprocessing the devices in section 9 reprocessing and maintenance.In addition, the user is recommended to check the device before and after each use see section 8 checks.The topic "hazard due to product combinations" has been included in the risk management file b6 reusable optical inserts, rev: r04.The overall probability of occurrence of this issue remains at the previously defined level and the overall risk of the product remains in the acceptable category.
Event or Problem Description
Richard wolf gmbh has been informed of an issue regarding a working element passive bipo 0/12/30°, part id: 8680.225, lot# 1546598.According to the received information, during a surgical procedure the conduction of energy that goes from the working element to the cutting handle was deficient.To counteract this deficiency the parameters of the generator had to be increased.This solution worked during the surgery, which allowed the procedure to be completed.Because of this failure, the surgery time was extended for more than 60 minutes.With the information currently available to rwgmbh from the questionnaire on incident (b)(4), no patient injury or patient risk is apparent.In addition, no other unexpected side effects were reported.

• 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 ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: valentin felsing ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 19311138
• Report Number: 9611102-2024-00018
• Device Sequence Number: 16919597
• Product Code: FDC
• UDI-Device Identifier: 04055207042953
• UDI-Public: 04055207042953
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2024

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: 1546598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• 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