FDA Adverse Event Malfunction Summary report: N

GOMCO

MDR report key: 22746167 · Received August 7, 2025

Report

Report Number: 1924066-2025-00057
Event Type: Malfunction
Date Received: August 7, 2025
Date of Event: July 8, 2025
Report Date: August 7, 2025
Manufacturer: ALLIED MEDICAL LLC.
Product Code: HFX
PMA / PMN Number: PREAMENDMENT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

TO DATE, WE HAVE NOT RECEIVED ANY SUPPORTING SAMPLES OR PHOTOGRAPHIC EVIDENCE; THEREFORE, WE ARE UNABLE TO SUBSTANTIATE THE REPORTED COMPLAINTS.

Description of Event or Problem · 0

WHEN TIGHTENING THE NUT OF THE GOMCO DEVICE WHERE THE BELL AND THE BEVEL HOLE OF THE PLATE MEET, INSTEAD OF PRODUCING A CRUSH INJURY, WE ARE NOTICING THAT THE DEVICE IS ACTUALLY CUTTING THE SKIN AND CAUSING SKIN SEPARATION WITH BLEEDING ON THE UNDERSIDE OF THE GOMCO DEVICE. THIS SKIN SEPARATION AND BLEEDING IS CONSISTENTLY HAPPENING PRIOR TO USE OF THE SCALPEL TO CUT THE EXCESS FORESKIN AWAY. UPON INSPECTION IT SEEMS THAT THE BEVELED DESIGN OF THE BELL ITSELF IS WHAT WE TYPICALLY SEE BUT THE HOLE IN THE BASE PLATE HAS A STRAIGHT EDGE TO IT INSTEAD OF THE SLIGHT SLANT TO IT AND LIKELY IS CREATING MORE OF A SHARP EDGE WHEN IN CONTACT WITH THE BELL. IT MAY BE CAUSING THE CUTTING INSTEAD OF THE TYPICAL EDGE OF FORESKIN OVER THE EDGE OF THE BELL WE SEE WHEN CUTTING WITH THE SCALPEL. THE IMMEDIATE SEPARATION OF SKIN IS LEADING TO BLEEDING DIFFICULT TO APPLY PRESSURE FOR HEMOSTASIS WITH THE GOMCO IN PLACE. THIS SAME SCENARIO HAS HAPPENED NO ON MULTIPLE OCCASIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
220703	GOMCO	500S CIRC CLAMP 1.1 CM	HFX	ALLIED MEDICAL LLC.	02-00-0500	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown