MAUDE Adverse Event Report: RICHARD WOLF GMBH GRASPING FORCEP INSERT

Model Number	8393.292
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic will follow up with the user facility and manufacturer to obtain additional and missing information.A follow up report will be submitted upon receipt of new or additional information.Rwmic considers this case open.
Event or Problem Description
On september 18, 2018, the user facility reported the following to richard wolf medical instruments (rwmic): the tip of the insert broke off in the patient.Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? yes.Specifically, was the device being used on a patient when the issue occurred? yes.Was there any injury or illness to patient or other personnel due to issue? no.Did the issue cause a delay in the procedure being performed that put the patient at risk? no.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.How was the patient anesthetized? unknown the other components of the modular system, the pistol shaped handle and the insulated sheath tube, are considered suspect devices and a report will be submitted for each device.Grasping forcep insert - product number 8393.292.Pistol shaped handle - product number 83930072 (mdr 1418479-2018-00033).Insulated sheath tube - product number 8393933 (mdr 1418479-2018-00034).
Event or Problem Description
User facility returned the device to rwmic on (b)(6) 2018 and the evaluation was completed on (b)(6) 2018.The device appeared to used and broken - the pull rod was broken distally at the transition to the joint part.The reported condition was verified using visual testing.The root cause was determined to be user handling issues, cause of the situation was due to a mechanical overload.Excessive force during gripping caused the distal end of the pull to break.No manufacturing defects were identified.
Additional Manufacturer Narrative
Device labeling was reviewed for patient code and device codes, see below: patient code: not applicable, no patient problem was reported.Device code: ifu was reviewed, see below: 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.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.Check the instruments and accessories for the following: damage, surface changes (e.G.Corrosion), sharp edges not suitable for the application, loose or missing parts, rough surfaces.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, user facility was contacted 3 times in an effort to collect additional information but none could be provided.Rwmic considers this case open.The manufacture will be contacted to collect missing information.A follow up report will be submitted upon receipt of new or additional information.

• Brand Name: GRASPING FORCEP INSERT
• Common Device Name: GRASPING FORCEP INSERT
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 7982482
• Report Number: 1418479-2018-00032
• Device Sequence Number: 13887902
• Product Code: GCJ
• UDI-Device Identifier: 04055207015988
• UDI-Public: 04055207015988
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2018
• Report Date (Section F): 12/21/2018

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: No Information
• Device Model Number: 8393.292
• Device Catalogue Number: 8393.292
• Device Lot Number: 51010295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/21/2018
• Event Location: Other
• Date Report to Manufacturer: 12/21/2018
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 12/21/2018