MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK; WORKING ELEMENT PASSIVE MONO

Model Number 8674225

Device Problems Break (1069); Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Rwmic considers this mdr/complaint open.Rwmic will submit a follow up report with additional information and investigation of this complaint.

Event Description

On october 5th , 2020, the user facility reported the following to richard wolf medical instruments corporation (rwmic): the loops were completely burning out and breaking during a turp- we went through 5 different loops in one case, and it ended up charring the end of the sheath, which led to bits of metal breaking off into the patients body.Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? no.Was there any injury or illness to any other personnel due to the reported issue? no.Did the issue cause a delay in the procedure being performed? yes.Did the delay put the patient at risk? (only applicable if there was a report of delay) unknown.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.

• Brand Name: SHARK
• Type of Device: WORKING ELEMENT PASSIVE MONO
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10755385
• MDR Text Key: 213888213
• Report Number: 1418479-2020-00265
• Device Sequence Number: 1
• Product Code: FDC
• UDI-Device Identifier: 04055207056714
• UDI-Public: 04055207056714
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/05/2020

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
• Device Operator: Health Professional
• Device Model Number: 8674225
• Device Catalogue Number: 8674225
• Device Lot Number: 1447623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/29/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/25/2020
• 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