MAUDE Adverse Event Report: RICHARD WOLF GMBH ERAGON MODULAR; SHEATH TUBE

Model Number	8393933
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf (b)(4).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
The user facility reported to richard wolf medical instruments that on (b)(6): during a gall bladder procedure this morning, one of the graspers the surgeon was using, which was the blunt grasper, when he put in through the trocar the coating from the sheath of the grasper flaked off into the patient's cavity.He stated he thought he was able to suck out most of it and irrigated the patient's abdomen.He is not pleased with the instruments at this point.This of course is a safety issue using the graspers.

• Brand Name: ERAGON MODULAR
• Common Device Name: SHEATH TUBE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 11581324
• Report Number: 1418479-2021-00008
• Device Sequence Number: 4881779
• Product Code: GCJ
• UDI-Device Identifier: 04055207016312
• UDI-Public: 04055207016312
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2021

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: 8393933
• Device Catalogue Number: 8393933
• Device Lot Number: 1454891
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1