MAUDE Adverse Event Report: RICHARD WOLF GMBH HF BIPOLAR CONNECTING CABLE L5M

Model Number	8108.252
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic is requesting additional and missing information from rw(b)(4).The device evaluation is underway but is not yet fully completed.Rwmic will submit a follow up report as appropriate when new/additional information becomes available.
Event or Problem Description
Richard wolf medical instruments corporation, hereinafter referred to as rwmic was notified on 8/23/2018 by richard wolf (b)(4), hereinafter referred to as rw(b)(4) of an incident that occurred on (b)(6) 2018.The user facility reported that during the use (cutting coagulation mode) by the doctor that the resectoscope stopped working in the middle of the operation and ignited the tissues.The flames caused severe burns on the patient.First investigations showed that a breakage of the cable had occurred.The isolation of the cable was damaged at the break so that the strand was exposed.

• Brand Name: HF BIPOLAR CONNECTING CABLE L5M
• Common Device Name: HF BIPOLAR CONNECTING CABLE L5M
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, gm 75438 ; GM 75438
• MDR Report Key: 7824438
• Report Number: 9611102-2018-00013
• Device Sequence Number: 2348142
• Product Code: FAS
• UDI-Device Identifier: 04055207000922
• UDI-Public: 04055207000922
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/30/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8108.252
• Device Catalogue Number: 8108.252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other