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

Model Number 8108.252

Device Problems Break (1069); Fire (1245); Structural Problem (2506); Power Problem (3010)

Patient Problem Burn(s) (1757)

Event Date 07/16/2018

Event Type  malfunction  

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 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
• Type of Device: HF BIPOLAR CONNECTING CABLE L5M
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, gm 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, gm 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; pforzheimer street 32; knittlingen, gm 75438 ; GM 75438
• MDR Report Key: 7824438
• MDR Text Key: 118544767
• Report Number: 9611102-2018-00013
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207000922
• UDI-Public: 04055207000922
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other