MAUDE Adverse Event Report: RICHARD WOLF GMBH INTESTINE GRASPER FORCEPS, INSERT; LAPROSCOPIC GRASPER CLAMP

Model Number	8393249
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic is pending the device evaluation.Upon receipt of new/additional information, a follow-up report will be submitted.Rwmic is submitting this report on behalf of (b)(4).
Event or Problem Description
On (b)(6) the user facility reported (medwatch) to richard wolf medical instruments that the grasper clamp piece broke off into the pt cavity; surgeon retried broken piece immediately.No harm to patient.
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Labeling review (ga-s027).Caution! excessive force can lead to breakage of or damage to the products.Due to the small dimensions required, the products have only limited strength.Use these products only to grasp and ablate small, soft tissue portions or organs.For therapeutic applications we recommend having a backup instrument at hand.Make sure that no missing parts remain in the patient.Note! when closing the handle (3) you will feel a resistance at a certain point caused by the overload protection.The overload protection exclusively serves the purpose of protecting the joint mechanism in the case of excessive forces applied during use.The handle can still be closed up to the stop.Caution! be careful if products are damaged or incomplete! injuries of the patient, user and 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.8.1 visual check the instruments and accessories for the following: damage surface changes (e.G.Corrosion) sharp edges not suitable for the application oose or missing parts rough surfaces.Any inscriptions or identification necessary for the safe intended use must be legible.To prevent incorrect handling or reprocessing, any illegible lettering, labeling or identification must be reinstated.Check the insulation of the hf cable for damage.Replace the hf cable if the insulation is damaged.Caution! damaged surface in the joint area of the forceps ! the joint pin may loosen.Check for surface changes, such as fissures, at the joint pin (fig.27) rwmic considers this mdr/complaint open.Rwmic will contact the user facility for missing patient information.
Event or Problem Description
Rwmic evaluation 09/24/2020: findings, insert 8393.249: the welding seams around all 4 rivets are cracked, but the rivets are present.The pullrod connector is broken just proximal of the segment connections, but all parts are present.Sheath 8393.933 / 1341886: distal end of sheath is deformed and bent.The condition of these 2 components of the modular system shows extreme mis-use of the bowel grasper.The joints were overloaded with grasping force, and the whole distal section of the instrument has been bent.The condition reported by the user facility is confirmed.Product disposition is scrap.Possible root cause is user error.
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments is the importer of this device.Per the user facility, no new information will be provided.Rwmic considers this mdr closed.

• Brand Name: INTESTINE GRASPER FORCEPS, INSERT
• Common Device Name: LAPROSCOPIC GRASPER CLAMP
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10532328
• Report Number: 1418479-2020-00024
• Device Sequence Number: 19739039
• Product Code: GCJ
• UDI-Device Identifier: 04055207055731
• UDI-Public: 04055207055731
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K935270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Other,Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2020

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
• Operator of Device: Health Professional
• Device Model Number: 8393249
• Device Catalogue Number: 8393249
• Device Lot Number: 4500222588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 09/24/2020; 09/24/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 10/01/2020; 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR