MAUDE Adverse Event Report: RICHARD WOLF GMBH FLEXIBLE BIOPSY FORCEPS

Model Number	828.07
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to richard wolf medical instruments corp (rwmic) by the customer, that they "were unable to open and close grasping forceps or biopsy forceps during a case." additional details: 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.
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.This mdr is being submitted as part of an ongoing retrospective review (remediation) of prior files by rwmic.Attempts were made to obtain additional information from the user facility, however the user facility responded that no further information would be provided.According to the investigation report: the pliers with the batch number 4500266933 were delivered on 01/24/2019 with of an order size of 100 pieces to the new goods warehouse.The delivery to the customer took place on 02/19/2019 the inspection revealed a broken drawbar.This means that it is not possible to transmit sufficient force to open and close the jaws.It is highly probable that the drawbar is broken during handling.In general, according to ga-s004, chapter 8 before and after each application to carry out a visual and functional test, products which are damaged parts may no longer be used.In our risk assessment b1-2, production-related and hazards and risks related to handling and design, which, as a result of a processing defect, can be turned into functional impairments can lead, considered and considering of the corresponding extent of damage and of the assumed probability of occurrence with an acceptable risk.The risk assessment is carried out under consideration of the current complaint and as there are no new risks, this continues to apply.Based on the results of our review, we have determined that the knowledge, can be derived from production-technical, respectively constructional view do not derive any systematic shortcomings.Corrective actions are not considered due to the comparable cases.Further measures are to be taken with regard to the findings of the evaluation.Currently not required.Richard wolf gmbh (rwgmbh) considers this matter closed.However, in the event rwgmbh receives any additional information a follow up report will be submitted to fda.

• Brand Name: FLEXIBLE BIOPSY FORCEPS
• Common Device Name: FLEXIBLE BIOPSY FORCEPS
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• MDR Report Key: 14569376
• Report Number: 1418479-2019-00057
• Device Sequence Number: 17617685
• Product Code: FCL
• UDI-Device Identifier: 04055207008195
• UDI-Public: 04055207008195
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K970162
• 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 Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2019

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: Health Professional
• Device Model Number: 828.07
• Device Catalogue Number: 828.07
• Device Lot Number: 4500266933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown