MAUDE Adverse Event Report: RICHARD WOLF GMBH FLEXIBLE BIOPSY FORCEPS

Model Number	829.07
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts were made to obtain additional information from the user facility, but none could be provided.The following patient and device codes related to the reported condition, are outlined in the device ifu: 7 checks: important! run through the checks before and after each use.Important! do not use damaged or incomplete products or products with loose parts.Return products together with loose parts for repair.Do not attempt to do any repair yourself.7.1 visual check: caution! check for surface changes (e.G.Hairline cracks) in the area of the joints and hinges of the jaws.In case of damage the hinge pin may become loose.Before and after each use, check instruments and accessories for damage, loose or missing parts and rough surfaces.Check jaws for defective cutting edges and corroded parts.The flexible sheath must not be kinked or otherwise damaged.7.2 functional check: the jaws must open and close easily.Rwmic considers this case closed.Should additional information become available, a follow up report will be submitted.
Event or Problem Description
On october 23, 2019 richard wolf medical instruments corp (rwmic) received the following information: per the customer, they were unable to open and close grasping forceps or biopsy forceps during a case.Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? yes.Specifically, was the device being used on a patient when the issue occurred? yes.Was there any injury or illness to patient or other personnel due to issue? no.Did the issue cause a delay in the procedure being performed that put the patient at risk? yes.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.How was the patient anesthetized? general.The user facility returned the device to richard wolf medical instruments corporation (rwmic) on october 25, 2019 and the device evaluation was completed on november 12, 2019.The device was functionally evaluated.The reported condition could not be verified as there were no defects found during evaluation.As a result, a probable root cause could not be determined.

• Brand Name: FLEXIBLE BIOPSY FORCEPS
• Common Device Name: FLEXIBLE BIOPSY FORCEPS
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 9365747
• Report Number: 1418479-2019-00055
• Device Sequence Number: 19484470
• Product Code: FCL
• UDI-Device Identifier: 04055207008249
• UDI-Public: 04055207008249
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K203866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2019
• Report Date (Section F): 11/22/2019

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: No Information
• Device Model Number: 829.07
• Device Catalogue Number: 829.07
• Device Lot Number: 4500268255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/23/2019
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 11/22/2019