MAUDE Adverse Event Report: RICHARD WOLF GMBH RIGID GRASPER FORCEPS; RIGID GRASPER FORCEPS 5FR WL 430MM

Model Number 864265

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/09/2021

Event Type  malfunction  

Event Description

It was reported to richard wolf by the user facility: description of incident/claim: during hysteroscope device broke; a screw uncoppled during procedure, afterwards it was hard to close the device but we succeeded.So we could get the device out.During removal of the device we saw the screw "swimming" in the uterus.We tried to find it with a new device but didn't succeed; so the screw most likely washed out via the cervix.But the left tuba looked more opened than before; did the screw passed the tube into the abdominal cavity? just to make sure we performed an x ray.On xray no screw was visible; too small/not more in patient? the patient is ok, we apologised.She's fine.No pain.

Manufacturer Narrative

The instrument has not yet been sent for examination by the user.As soon as the examination is completed, we will send a follow-up report.Rw (b)(4) considers this report open.Rw (b)(4)h will submit a follow up report after the device evaluation has been completed and/or new information becomes available.

Manufacturer Narrative

Follow-up report #1 is to provide fda with the results of the device evaluation - see below (h10).The manufacturer reports: the inspection in the responsible specialist department showed that the tie rod had been mechanically overloaded.In addition, heavy impurities were found in the jaw section, which worsened the ease of movement of the joint area.In our opinion, the cause of the breakage of the tie rod can be traced back to a mechanical overload combined with a massive cleaning deficit.The 864265 rigid grasper forceps 5fr wl 430mm originates from the production batch 4500174592 and was booked to the new goods warehouse on july 31, 2015 with an order size of (b)(4) pieces.The check of the production flow chart did not show any return deliveries or special releases within the production lot.The delivery to the customer took place on (b)(6) 2017.Dirt that is not properly removed becomes lodged in the joint mechanism, which leads to a sluggishness of the joint mechanism during use and more force has to be applied to be able to perform the intended application.As a result, there is an increased risk of breakage.The user is informed in ga-e193 and in ga-j020, which is also applicable, about the proper use of the pliers and cleaning.Excessive use of force can lead to breakage or damage to the product, which can impair its function.Furthermore, the user is advised to perform a visual and functional check after each reprocessing and before each use.The opening and closing of the joints should be smooth.If the information in the instructions for use is observed, damage or functional impairment can be detected at an early stage and the product is sorted out before use.In the b1-2 r03 risk assessment, possible risks including handling-related hazards were considered with the corresponding extent of damage and the assumed probability of occurrence and assessed as an acceptable risk.This assessment is still valid even taking into account the current case.Richard wolf gmbh considers this matter closed.However, in the event rwgmbh receives any additional in-formation a follow up report will be submitted to fda.Richard wolf medical instruments corporation(rwmic) submitting report on behalf of rwgmbh report.Rwmic is submitting this report for the manufacturer richard wolf gmbh.

Event Description

Please see manufacturers narrative for results of the device investigation.

• Brand Name: RIGID GRASPER FORCEPS
• Type of Device: RIGID GRASPER FORCEPS 5FR WL 430MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• MDR Report Key: 13395896
• MDR Text Key: 287931846
• Report Number: 9611102-2022-00001
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2022

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: 864265
• Device Catalogue Number: 8642.65
• Device Lot Number: 4500174592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2022
• Initial Date FDA Received: 01/31/2022
• Supplement Dates Manufacturer Received: 02/17/2022
• Supplement Dates FDA Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2017
• 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