MAUDE Adverse Event Report: RICHARD WOLF GMBH; CONNECTION CABLE WL 3M

Model Number	8564851
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility has informed richard wolf medical corporation (rwmic) of an issue regarding a connection cable wl 3m, part id: 8564.851, batch# 230372.According to the received information, the user indicated that the connection between the motor control unit, connection cable, and the handpiece had been interrupted.Due to it, the motor control unit failed to recognize the handpiece.The connection cable was checked, and no bent pins were found.The reported event happened on a third case, at the beginning of a holmium laser enucleation of the prostate (holep) procedure but prior to being used on the patient.However, there was a reported 15-minute delay troubleshooting the device.The procedure was not completed, and the patient was brought back 2 days later for morcellation.Another connection cable was used, and it worked fine.
Additional Manufacturer Narrative
Based on the information, richard wolf consider this case to be a reportable "serious injury" due to "aborted procedure".
Additional Manufacturer Narrative
The following fields have new information: a1, a2, a3a, a5, a6, b4, g3, g6, h2, h6 (type of investigation, investigation findings, and investigation conclusions), h7, and h11.The connection cable, 8564.851, was investigated and the rear plastic outer sheath of the metallic part of the plug from the motor side was found loose and twisted uncontrollably.Also, the strands in the plug were broken.The strands may have been broken by torsion, which can only occur when plug is pulled out under these conditions.Why the plug was loose is unknown.Based on this information, the root cause was determined to be a user error.The date of manufacture of the connection cable wl 3m, part id: 8564.851, batch# 230372, is unknown.A general product problem can be ruled out.An evaluation of comparable cases/complaints from the last 10 years did not yield any.The instructions for use, ga-a202-us /en/ 2020-10 v2.0 / pk20-0329 and ga-a238-us /en/ 2020-12 v6.0 / pk20-0352, contains several safety instructions and notes on "loose or damaged parts" in section 4 "checks".It is pointed out that a visual and functional check must be carried out before and after each use.The subject issue of "disconnection" is present in the risk management file "e5-1: control units with accessories" v00.The overall probability of occurrence for this issue remains at previously defined levels and the overall risk of the device remains in the acceptable category.

• Common Device Name: CONNECTION CABLE WL 3M
• 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: 20369024
• Report Number: 9611102-2024-00034
• Device Sequence Number: 6878196
• Product Code: GEY
• UDI-Device Identifier: 04055207066676
• UDI-Public: 04055207066676
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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
• Device Model Number: 8564851
• Device Catalogue Number: 8564.851
• Device Lot Number: 230372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HANDPIECE: POWER STICKS.; MOTOR CONTROL UNIT: POWER DRIVE ART1.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White