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

Model Number	8650.624
Medical Device Problem Codes	Failure to Power Up (1476); Blocked Connection (2888); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: COAG. BIOPSY FORCEPS BY TAUBER
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 12051854
• Report Number: 1418479-2021-00023
• Device Sequence Number: 3502418
• Product Code: FBO
• UDI-Device Identifier: 04055207018408
• UDI-Public: 04055207018408
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K011496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR