MAUDE Adverse Event Report: RICHARD WOLF GMBH ERAGON MODUBLADES; METZENBAUM SCISSORS ATTACHMENT MONO

Model Number	4393040
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additionally, according to the information received from the report, it was unclear how the insulation broke, whether it was defective from the start or whether it was a user error.The insulation is similar to shrink tubing used for electrical cables.
Event or Problem Description
It was reported that during a laparoscopic procedure, the insulation on the laparoscopic scissors broke and a piece of plastic insulation came loose in the patient's abdomen.The loose piece was found and removed.

• Brand Name: ERAGON MODUBLADES
• Common Device Name: METZENBAUM SCISSORS ATTACHMENT MONO
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 22070385
• Report Number: 9611102-2025-00022
• Device Sequence Number: 21010290
• Product Code: GCJ
• UDI-Device Identifier: 04055207048658
• UDI-Public: 04055207048658
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K935270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 4393040
• Device Catalogue Number: 4393.040
• Device Lot Number: 848270
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown