MAUDE Adverse Event Report: ALLIED MEDICAL LLC. GOMCO; 500 CIRC CLAMP , EX SMALL , 1.1 CM

Model Number	02-00-0500
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
I wanted to bring to your attention that we experienced a malfunction with a gomco 1.1cm clamp during a recent procedure last week.This is not the first time that they have encountered this issue.The clamp did not completely close, causing the skin to slip through and not completing the cut.I was unable to locate a serial number on the clamp, but the manufacturer date is 20240126.
Additional Manufacturer Narrative
No samples returned so could not check the validity of the complaints.

• Brand Name: GOMCO
• Common Device Name: 500 CIRC CLAMP , EX SMALL , 1.1 CM
• Manufacturer (Section D): ALLIED MEDICAL LLC.; 1720 sublette ave; st. louis MO 63110
• Manufacturer (Section G): ALLIED MEDICAL LLC; 1720 sublette ave; st. louis MO 63110
• Manufacturer Contact: nicole szakats ; 1720 sublette ave; st. louis, MO 63110 ; 3147712400
• MDR Report Key: 21364364
• Report Number: 1924066-2025-00032
• Device Sequence Number: 12870445
• Product Code: HFX
• UDI-Device Identifier: 00026072002292
• UDI-Public: (01)00026072002292(11)20240126
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2025

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
• Device Model Number: 02-00-0500
• Device Catalogue Number: 02-00-0500
• Device Lot Number: 20240126
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2024
• 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