MAUDE Adverse Event Report: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG GOLD-CUT HERCULES® SURG WIRE CUTTER 18CM

Catalog Number	OS3032 / OL 603-18-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a cabg procedure, the black rubber tip insert of the wire cutter cracked in half.A piece fell into the patient's body and was retrieved by the surgical team.No additional medical procedure was required for verification purposes and the procedure was completed as planned.
Additional Manufacturer Narrative
The rubber tip insert material was inspected.A piece had broken off, which can happen to material that is otherwise in good condition if the piece of wire to be cut is too short and cuts into the rubber.Device manufacturing history was checked and no issues were found.The problem can be attributed to user error.

• Brand Name: GOLD-CUT HERCULES® SURG WIRE CUTTER 18CM
• Common Device Name: WIRE CUTTER
• Manufacturer (Section D): GEOMED MEDIZIN-TECHNIK GMBH & CO. KG; ludwigstaler strasse 27; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): GEOMED MEDIZIN-TECHNIK GMBH & CO. KG; ludwigstaler strasse 27; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: hanno haug ; ludwigstaler strasse 27; tuttlingen, bw 78532 ; GM 78532
• MDR Report Key: 17742955
• Report Number: 8010168-2023-00007
• Device Sequence Number: 4085636
• Product Code: HXZ
• UDI-Device Identifier: 10885403102769
• UDI-Public: (01)10885403102769
• Combination Product (Y/N): N
• Initial Reporter State: MH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/14/2023

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: Health Professional
• Device Catalogue Number: OS3032 / OL 603-18-01
• Device Lot Number: K22XBF / 151
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown