MAUDE Adverse Event Report: RICHARD WOLF GMBH FORCEPS, GRASPING, SEMI-RIGID; RIGID GRASPER, FORCEPS 5 FR

Model Number 8642.65

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4) considers this mdr/complaint open.(b)(4) will submit a follow up report after the ifu ga-e193 has been reviewed, the product history evaluation has been completed and/or new information becomes available.

Event Description

On march 22, it was reported to richard wolf that "the pin at apex of grasper fell out into a patient.No patient or staff injury reported".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 three times in an effort to collect patient information and user information.As of (b)(6) 2021, rwmic has not received a response.Rwmic considers this mdr closed.Rwmic will submit a follow up report is we receive new information.

Event Description

The purpose of this submission is to report the results of the product history evaluation since the device was not returned.The review found: "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 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 the relevant data does not show signs of systematic errors or manufacturing errors, no further action is necessary.".

• Brand Name: FORCEPS, GRASPING, SEMI-RIGID
• Type of Device: RIGID GRASPER, FORCEPS 5 FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 11656464
• MDR Text Key: 246770914
• Report Number: 1418479-2021-00010
• 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,other,use
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

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 Catalogue Number: 8642.65
• Device Lot Number: 4500303443
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2021
• Initial Date FDA Received: 04/13/2021
• Supplement Dates Manufacturer Received: 09/09/2021
• Supplement Dates FDA Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1