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

Model Number 8642.65

Device Problem Material Separation (1562)

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

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.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 by the user facility: "pin holding jaws together fell out.This happened before they were going to use the items." will the device be returned? yes.Was the device being used on a patient when the reporting issue occurred? no.Was there any injury or illness to the patient due to the reported issue? n/a.Was there any injury or illness to any other personnel due to the reported issue? n/a.Did the issue cause a delay in the procedure being performed? n/a.Did the delay put the patient at risk? n/a.Was there a similar backup device available for use? n/a.Was the scheduled procedure completed? n/a.The facility is returning three devices, all from the same lot.

Manufacturer Narrative

Follow-up report #1 is to provide fda with missing information, new information, and changed information.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 closed.Rwmic will submit a follow up report if new information becomes available.Missing information: user facility was contacted 3 times in an effort to collect patient information and user information.As of 8/11/2021, rwmic has not received a response.Device labeling was reviewed for patient code and device codes, see below: ifu ga-e193.Checks: check instruments and accessories for damage, hygienic condition and completeness.The joints and hinges must open and close easily.Ifu ga-j020 (recommended in ifu ga-e193 that (further notes and instructions on reprocessing are described in manual ga-j020 "reprocessing of richard wolf heat-stable instruments", and these must be followed.).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, any lettering, labeling or identification necessary for the safe intended use must be legible.

Event Description

The purpose of this submission is to report the findings of the device investigation/evaluation.Rwmic received and visually evaluated the devices.The reported conditioned (pin holding jaws together) was verified.It was found that the pin came loose from normal wear (root cause: wear and tear), aggravated by being used while the shaft was bent.Device was not sent for regular maintenance.It was recommended the devices be scrapped.

• Brand Name: WOLF LAPARASCOPIC GRASPING FORCEP
• Type of Device: GRASPING FORCEP
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 12001885
• MDR Text Key: 265195678
• Report Number: 1418479-2021-00024
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

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: No Information
• Device Model Number: 8642.65
• Device Catalogue Number: 8642.65
• Device Lot Number: 4500303443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Initial Date Manufacturer Received: 06/04/2021
• Initial Date FDA Received: 06/15/2021
• Supplement Dates Manufacturer Received: 07/15/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1