MAUDE Adverse Event Report: RICHARD WOLF GMBH LAPAROSCOPIC GRASPING FORCEPS

Model Number 8642.65

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf (b)(4).Richard wolf medical instruments corporation is the importer of this device.Labeling review (ifu and reprocessing guide) has the following warning and cautions: checks and maintenance: caution! be careful if products are damaged or incomplete! injuries to the patient, user or others are possible.Run through the checks before and after each use.Do not use the products if they are damaged, incomplete or have loose parts.Return damaged products together with any loose parts for repair.Do not attempt to do any repairs yourself.Visual check: check the products for the following: damage.Sharp edges.Loose or missing parts.Rough surfaces.Note: tighten all screw connections before use.The device is not being returned.Rwmic considers this mdr/complaint closed, a report will be submitted should new information become available.

Event Description

On march 5, 2021, richard wolf received medwatch report (b)(4).It was reported that "during a hysteroscopy, a screw broke off a lap grasper while removing polyps.Screw was removed safely.Patient was further assessed by surgeon and determined there was no longer a foreign object in the uterine cavity.The device was removed from use and tagged for repair." contact with the initial submitter revealed that: will the device be returned? no.Was the device being used on a patient when the reported 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? no.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.

Event Description

The device was not returned for investigation so a review of the product history was completed.Richard wolf gmbh reported: richard wolf gmbh has not received any complaints about the forceps 8642.65 outside the us in the last three years.The complaint rate of this forceps is very low.Based on our experience 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 1,7 mm the instrument is not suitable for applying 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 results 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.

Manufacturer Narrative

Richard wolf medical instruments (mic) is submitting this report on behalf of richard wolf gmbh.Mic is the importer of this device.Follow-up report #1 is to provide fda with missing, new, and changed information.Rwmic considers this mdr open pending due diligence.

• Brand Name: LAPAROSCOPIC GRASPING FORCEPS
• Type of Device: FORCEPS
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 11576307
• MDR Text Key: 274082679
• Report Number: 1418479-2021-00007
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

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
• Device Operator: Health Professional
• Device Model Number: 8642.65
• Device Lot Number: 4500173150
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 03/26/2021
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR