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

Catalog Number OS3032 / OL 603-18-01

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/14/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 324062740
• Report Number: 8010168-2023-00007
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10885403102769
• UDI-Public: (01)10885403102769
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OS3032 / OL 603-18-01
• Device Lot Number: K22XBF / 151
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1