MAUDE Adverse Event Report: RICHARD WOLF GMBH ERAGON MODULAR; METZENBAUM SCISSORS INSERT Ø 5MM

Model Number	8393041
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility claimed that "we were faced with the same problem with 2 metzenbaum scissor inserts (ref: 8393.041) delivered on (b)(6).During operations, the jaws of the scissors became unsuitable.One of them was used once, the other was used three times.They are part of the same batch (1516371)." there was no harm to the patient and no component of the scissors was lost.The treatment was completed with another pair of scissors, but there was a surgery delay of 1 hour.
Additional Manufacturer Narrative
The metzenbaum scissors insert ø 5mm, part no.8393041 batch 1516371 was manufactured on 21/jul/2022.No other complaints for this batch were identified.The examination of the two metzenbaum scissors inserts revealed that the scissor blades have jumped out of the calotte guide in each case.The cause of the damage cannot be clearly determined.One possible cause is due to excessive torsional forces.In the associated instructions for use, ga-s027 / en / 2019-11 v10.0 / pk19-9850, the user is informed about the limited strength of the device in section 10 use.The subject issue of avoiding excessive force in use of the device is present in the risk management file b1-211 - reusable rigid energetic forceps and scissors, rev.V00.The overall probability of occurrence for this issue remains at previously defined levels and overall risk of the device remains in the acceptable category.

• Brand Name: ERAGON MODULAR
• Common Device Name: METZENBAUM SCISSORS INSERT Ø 5MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438, knittlingen, germany ; GM
• Manufacturer Contact: philipp schmidt ; pforzheimer strasse 32; d-75438, knittlingen, germany ; GM
• MDR Report Key: 16380840
• Report Number: 9611102-2023-00009
• Device Sequence Number: 15002977
• Product Code: GCJ
• UDI-Device Identifier: 04055207015711
• UDI-Public: 04055207015711
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/15/2023

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: Other
• Device Model Number: 8393041
• Device Catalogue Number: 8393.041
• Device Lot Number: 1516371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown