MAUDE Adverse Event Report: RICHARD WOLF GMBH WOLF LAPAROSCOPIC GRASPING FORCEP

Model Number 8642.65

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/26/2021

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 open.Rwmic will submit a follow up report after the device evaluation has been completed and/or new information becomes available.

Event Description

It was reported to richard wolf that "during the procedure, a forceps instrument with graspers was inserted into the uterus.The device was initially intact and was introduced without resistance or difficulty.When attempting to use the instrument it stopped working.Upon removal a small piece of metal presumed to be a screw was noticed floating in the solution that had been instilled into the uterus.Attempts were made to snare it until at one point the metal piece could no longer be seen in the uterus.The hysteroscopy was completed.Following the procedure a search was conducted for the screw but it could not be found." there were two other events recently reported of metal screws coming loose from forceps during hysteroscopies.In both cases the screws were retrieved and removed.Original procedure: hysteroscopy.Additional information: 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? no.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Follow-up report #1 is to provide fda with missing information, new information (product history evaluation report), and changed information.Missing information: user facility/surgeon was contacted 3 times in an effort to collect patient information and user information.As of 03/1/2022, rwmic has not received a response.Rwmic considers this mdr closed.Should rw receive new information, a follow-up report will be submitted.

Event Description

The purpose of this report is to submit the product history evaluation report to the fda.The device was not returned to richard wolf.Product history evaluation as reported by rw gmgh: richard wolf gmbh has not received any complaints about the forceps 8642.65 outside the us since year 2014.The complaint rate of this forceps is very low.Because the instrument will not be returned for investigation, a detailed evaluation is not possible in this case.Based on our experiences of older complaints the most probable root cause of the described damage is due to overload of the instrument.As the forceps has only a diameter of 1.7mm at distal jaw part the instrument is not suitable for apply excessive force.In order to avoid overloading, the users are advised in the ifu ga-e193 that the product has only limited strength.Excessive force may cause the instruments to break.As a result of the necessary small dimensions, the distal sections of the instruments have only limited stability.As the review of the relevant data does not show signs of systematic errors or manufacturing errors, no further action is necessary.Rwmic considers this mdr closed.Should rw receive new information, a follow-up report will be submitted.

• Brand Name: WOLF LAPAROSCOPIC GRASPING FORCEP
• Type of Device: GRASPING FORCEP
• 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: 11740937
• MDR Text Key: 267300263
• Report Number: 1418479-2021-00016
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

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: 8642.65
• Device Catalogue Number: 8642.65
• Device Lot Number: 4500303443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 04/28/2021
• Supplement Dates Manufacturer Received: 04/13/2021
• Supplement Dates FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2020
• 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 Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Female