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

Model Number 815033

Device Problems Material Separation (1562); Electrical Shorting (2926)

Patient Problem Insufficient Information (4580)

Event Date 01/11/2024

Event Type  malfunction  

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 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.

• Type of Device: 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
• MDR Text Key: 336214357
• Report Number: 9611102-2024-00004
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K982677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 815033
• Device Catalogue Number: 815.033
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1