MAUDE Adverse Event Report: RICHARD WOLF GMBH; HF CONNECTION CABLE MONO L 3M

Model Number	815033
Medical Device Problem Codes	Material Separation (1562); Electrical Shorting (2926)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been submitted without any information's regarding the specific event and patient situation.Therefore, it is not possible to evaluate the case.Also, the serial/batch number were not provided, the device and complaint history analysis cannot be performed as well.The hf connection cable 815.033 was not returned for investigation as it was destroyed (scrapped).Therefore, the root cause of the device problem, cord breaking apart cannot be determined.In general, the instruction for use ga-s009 / en / 2020-08 v4.0 / drd&d_imp_1 / contains information on warning and attention in chapter 9 "checks".In addition, chapter 9.1 "service life" refers to careful and gentle handling as well as the user's behavior in the event of non-compliance with the above-mentioned control points.Possible hazards were assessed as acceptable in the risk assessment "f2-1 reusable hf/rf cables" vo1, taking into account the respective extent of damage and the probability of occurrence.
Event or Problem Description
An importer has informed richard wolf gmbh (rwgmbh) of an issue regarding a hf connection cable mono l 3m, part id: 815.033, sn/batch# unknown.The information was received from a "user-notification" report no.(b)(4).According to the report, the cord shorted out and blew apart.No further information was provided regarding the patient's outcome or any other risks or injuries.It is also not known if there was a time delay in the procedure.

• Common Device Name: HF CONNECTION CABLE MONO L 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: 18678857
• Report Number: 9611102-2024-00004
• Device Sequence Number: 12566977
• Product Code: GEI
• UDI-Device Identifier: 04055207000236
• UDI-Public: 04055207000236
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K982677
• 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): 02/09/2024

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: 815033
• Device Catalogue Number: 815.033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown