MAUDE Adverse Event Report: RICHARD WOLF GMBH RIGID BIOPSY FORCEPS; RIGID BIOPSY FORCEPS 5FR WL 340MM

Model Number 8642.60

Device Problem Detachment of Device or Device Component (2907)

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 product history evaluation has been completed and/or new information becomes available.

Event Description

On april 6, 2021 the user facility reported to richard wolf that the "pin at apex of scissors fell out into patient." the date of the procedure is unknown.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? yes.Did the delay put the patient at risk? yes.Was there a similar back-up device available for use? no.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, and changed information.Missing information: user facility was contacted 3 times in an effort to collect patient information and user information.As of 10/8/2021, rwmic has not received a response.Device labeling was reviewed for patient code and device codes, see below: 1 intended use.The biopsy forceps are used for soft tissue (connective tissue) biopsies.The biopsy forceps with cutting jaws are used for the removal of small parts of soft tissue.6 application.Caution! the instrument could become kinked! when working with these instruments, excessive load may cause them to brake near the handle.Guide the distal instrument tip only via the hysteroscope or cystoscope sheath.Note: 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.Do not use these instruments for grasping and removing of large pieces of tissue.Rwmic considers this mdr closed.Rw mic will submit a follow up report if new information becomes available.

Event Description

The purpose of this submission is to provide fda with the product history evaluation.The user facility did not return the device to the manufacturer or importer for investigation.Rw gmbh reports that "richard wolf gmbh has not received any complaints about the forceps 8642.60 outside the us within the last three years.During the same time there were sold 248 pieces of these forceps worldwide.The above mentioned forceps with batch #: 4500276023 was delivered from our supplier to rw gmbh on 06/03/2019 with a lot size of (b)(4) pieces.Eight forceps from this lot were sent to rw mic with delivery note (b)(4) on 01/16/2020.Based on our experiences from older complaints of similar forceps the most probable root cause of the described damage is due to overload of the instrument.As the forceps has only a diameter off 1.7 mm at distal jaw part of 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 result of the necessary small dimensions, the distal sections of the instruments have only limited stability.' as the review of all available data does not show signs of systematic errors or manufacturing errors, no further action is necessary.".

• Brand Name: RIGID BIOPSY FORCEPS
• Type of Device: RIGID BIOPSY FORCEPS 5FR WL 340MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 11664178
• MDR Text Key: 274083420
• Report Number: 1418479-2021-00011
• 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: company representative,other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

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: 8642.60
• Device Catalogue Number: 8642.60
• Device Lot Number: 4500276023
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 10/08/2021
• Supplement Dates FDA Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1