MAUDE Adverse Event Report: RICHARD WOLF GMBH WOLF LAPARASCOPIC GRASPING FORCEPS; FORCEPS, GENERAL & PLASTIC SURGERY

Model Number	8642.65
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Richard wolf mic received a medwatch report #(b)(4) on july 13, 2020.Richard wolf mic will contact the user facility and manufacturer to gather additional information.Upon receipt of new information on a follow-up report will be submitted.
Event or Problem Description
Screw had fallen out of grasper during laparoscopic procedure.Grasper no longer works and was removed from patient.Screw was also removed from patient.No patient harm.
Event or Problem Description
Rwmic reached out to initial reporter for additional information.According to the initial reporter, no additional information can be provided.All the information were provided in the medwatch report # 4200070000-2020-8005.Rwmic evaluation (b)(6) 2020: the device was evaluated and the following were recorded: findings: jaws broken due to missing pin, it was noticed that forceps was over forced causing jaws to brake.The condition reported by the user facility is confirmed.Product disposition is scrap.Possible root cause is the mishandling of the device by user facility.
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.Labeling review ( ga-e193).Checks: check instruments and accessories for damage, hygienic condition and completeness.Do not use instruments which have a damaged cutting edge.Replace damaged instruments.Caution! the instrument could become kinked! when working with these instruments, excessive load may cause them to brake near the handle.Guide the distal instrument tip only via the hysteroscope or cystoscope sheath.Note! excessive force may cause the instruments to brake.As a result of the necessary small dimensions, the distal sections of the instruments have only limited stability.Do not use these instruments for grasping and removing of large pieces of tissue.Important! the forceps/scissors cannot be disassembled.Rwmic considers this mdr/ complaint closed.However, in the event rwmic receives any additional information a follow up report will be submitted to fda.

• Brand Name: WOLF LAPARASCOPIC GRASPING FORCEPS
• Common Device Name: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10296420
• Report Number: 1418479-2020-00012
• Device Sequence Number: 10891566
• Product Code: OCZ
• UDI-Device Identifier: 04055207057940
• UDI-Public: 04055207057940
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020
• Report Date (Section F): 07/01/2020

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
• Operator of Device: Health Professional
• Device Model Number: 8642.65
• Device Catalogue Number: 8642.65
• Device Lot Number: P707159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Distributor Facility Aware Date: 07/13/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2020
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR