MAUDE Adverse Event Report: RICHARD WOLF GMBH ERAGON MODULAR; DEBAKEY FORCEPS - INSERT

Model Number	8394258
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
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.Rwmic considers this mdr/complaint open.Rwmic will submit a follow up report after the device evaluation has been completed and/or new information becomes available.
Event or Problem Description
It was reported to richard wolf by the user facility that "a laparoscopic bariatric grasper came apart in the patient.The small piece was in the abdomen and found later during the case.An x-ray was performed to ensure no other pieces were left in the patient." additional details: will the device be returned? yes.Was the device being used on a patient when the reporting 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? no.Did the delay put the patient at risk? no.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.
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.Device labeling was reviewed for patient code and device codes, 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.Rwmic considers this mdr closed.Rwmic will submit a follow up report should new information become available.
Event or Problem Description
Rw mic received a response from the user facility with additional information: procedure: robotic low anterior resection and creation of diverting loop ileostomy, flexible sigmoidoscopy.Device failure happened while the instrument was being used intraoperatively.This was after the patient was asleep and insufflation was complete.This was a robotic case so we were using trochars, scope, electrocautery generator and camera.The device was returned to richard wolf and a visual inspection was completed.The investigation found that one side of the fork, which encloses the hinges, is broken off and is not present.Also missing are at least two connecting pins and two guide pins.It seems that a lot of lateral force was applied to the jaws, which caused the fork to break.These are relatively long jaws, and this leverage can create a lot of internal strain.Care must be taken not to overload the delicate components.The root cause was attributed to human error.The device was scrapped.

• Brand Name: ERAGON MODULAR
• Common Device Name: DEBAKEY FORCEPS - INSERT
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 11855436
• Report Number: 1418479-2021-00020
• Device Sequence Number: 3846996
• Product Code: GCJ
• UDI-Device Identifier: 04055207056059
• UDI-Public: 04055207056059
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: distributor,health profession
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

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
• Operator of Device: Health Professional
• Device Model Number: 8394258
• Device Catalogue Number: 8394258
• Device Lot Number: 4500263594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CAMERA; ELECTROCAUTERY GENERATOR; SCOPE; TROCARS
• Patient Age: 81 YR
• Patient Weight: 97