MAUDE Adverse Event Report: RICHARD WOLF GMBH HYSAFE; GRASPER, FORCEPS INSERT 4 FR WL

Model Number 89526118

Device Problem Material Separation (1562)

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

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh (manufacturer).Rw gmbh considers this mdr/complaint open and 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 rw that "the use of this device was discontinued because the forceps tip part was observed to be broken or defective during manipulation.Since it was during the procedure, there is a risk that the forceps parts remained or dropped.According to the pictures, the pin is missing.The user stated that there was no consequence to the patient.

Event Description

The purpose of this submission is to report the results of the device investigation.Please see manufacturers narrative.

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Follow-up report #1 is to provide fda with results of the device investigation.New information: the following fields have new: b5, d9, g6, h6, h10.Investigation report from rw gmbh states: the returned product was investigated in the responsible department.The investigation has shown that the forceps pipe is severely bent, no joint connection (hinge pin) is recognizable any more, so that the function of the grap forceps is no longer given.The hinge pin is brocken in the jaw section and it is missing.The cause is due to mechanical overload.The reported grasp.Forceps insert 4fr wl 550mm 89526118 has been in the program since 10/06/204.Rw gmbh has received in two deliveries from the affected batch 4500231448 of the grasp.Forceps in-sert 4fr wl 550mm from its supplier: 11/23/2017 - 30 pcs, 11/30/2017 - 90pcs.There is no information about when the customer received a product from the affceted batch 4500231448.No other complaints were received from the affected batch 4500231448.The user is informed in the affected ifu ga-s016 / en-us / 2015-03 v2.0 / eco 2015-0052 about the following safety instructions: 7 use.Caution! the products have only limited strength! these forceps are equipped with an overload protection guaranteeing clearly enhanced safety during use.Excessive force, however, will cause damage, impair the function and therefore endanger the patient.Immediately before and after each use, check the products for damage, loose parts and completeness.Make sure that no missing parts remain in the patient.Do not use the products if they are damaged or incomplete or have loose parts.8 checks.Caution! be careful if products are damaged or incomplete! injuries of the patient, users or third parties 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 carry out any repairs yourself.8.1 visual check.Caution! check for surface changes (e.G.Hairline cracks) around the hinge pin (s).The hinge pin (s) can loosen if the surface is damaged.Do not use instruments with damaged surfaces.Return instruments to the factory for repair! in the risk assessment b1-2 reusable non-optical forceps and scissors rev.05, production-related, handling and design hazards with regard to a functional impairment as well as risks from a product that cannot be used were considered with the corresponding extant of damage and the assumed probability of occurrence and evaluated with an acceptable risk.Furthermore, the affected product is to be used in urological field for the indications lithotripsy in the kidney and lithotripsy in the ureter.In case of part loss, the lost particles can be excreted from the body through the body in natarul way.Since no new risks have arisen from the investigation of the current incident, the risk assessment remains valid in view of the described facts.In summary, rw gmbh assumes that a user error was the cause of the damage.The instructions for use in sec-tion 7 and 8.1 were not followes.These explicitly point out the limited stability of the product and the visual inspection of the surface in the joint area.Excessive use of force leads to damage, impairs the function and thus endangers the patient.Damaged surface in the joint area of the forceps can cause the hinge pin to loosen, therefore attention must be paid to any surface changes during visual inspection.If the surface in the joint area is already damaged, a slightly stronger use of force can already cause damage to the product.Richard wolf gmbh(rwgmbh) considers this matter closed.However, in the event rwgmbh receives any additional information a follow up report will be submitted to fda.Richard wolf medical instruments corporati-on(rwmic) submitting report on behalf of rwgmbh report on behalf of rwgmbh.

• Brand Name: HYSAFE
• Type of Device: GRASPER, FORCEPS INSERT 4 FR WL
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 12241703
• MDR Text Key: 265993397
• Report Number: 9611102-2021-00028
• Device Sequence Number: 1
• Product Code: OCZ
• Combination Product (y/n): N
• PMA/PMN Number: K051276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89526118
• Device Catalogue Number: 8952.6118
• Device Lot Number: 4500231448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2021
• Date Manufacturer Received: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other