MAUDE Adverse Event Report: RICHARD WOLF GMBH N/A; COAG. BIOPSY FORCEPS BY TAUBER

Model Number 8650.624

Device Problems Failure to Power Up (1476); Blocked Connection (2888); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2021

Event Type  malfunction  

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Rwmic considers this mdr/complaint closed.Rwmic will submit a follow up report if new information becomes available.Results of the device investigation revealed the reported condition, forceps would not function when attached to cautery cord, was verified.The device was evaluated using visual, functional and electrical test methods and it was found that the jaws were dull and not cutting cleanly enough to form a closed circuit, fairly normal wear and tear when used frequently.In the ifu, ga-d324, the user is told to "run through the checks before and after each use", "important: do not use products which are damaged or incomplete or have loose parts.Return damaged products together with the loose parts for repair.Do not attempt to do any repairs yourself".

Event Description

It was reported to richard wolf by the user facility: customer was using the tauber forceps during a case, attached to the cautery cord and would not function.Tried another cautery and still did not work.Opened a green bugbee and attached to cautery coard and used that on the patient.The patient was under anesth.Longer than anticipated due to getting equipment/instrument that worked.Additional details (due diligence): procedure: tur bladder tumor.Device settings: unknown, instrument never worked once hooked up to cautery.Will the device be returned? yes.Was the device being used on a patient when the reporting 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? yes.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.Results of the device investigation in the manufactuers narrative.

• Brand Name: N/A
• Type of Device: COAG. BIOPSY FORCEPS BY TAUBER
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 12051854
• MDR Text Key: 267299744
• Report Number: 1418479-2021-00023
• Device Sequence Number: 1
• Product Code: FBO
• UDI-Device Identifier: 04055207018408
• UDI-Public: 04055207018408
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011496
• 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
• Type of Report: Initial
• Report Date: 05/26/2021

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: 8650.624
• Device Catalogue Number: 8650.624
• Device Lot Number: 1410270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/23/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2019
• 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
• Patient Age: 42 YR