inforMED
MalfunctionHFX

GOMCO

Received Jun 12, 2026 · Event occurred May 27, 2026

Report 1924066-2026-00009 · MDR key 25487649

Device

Generic name

500s Circ. Clamp Ex Small 1.1

Model number

02-00-0500

Catalog number

02-00-0500

Lot number

20250820

Product problems

  • Insufficient Device Problem Information

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

WAS USED ON A PATIENT AT THE TIME OF NOTICING THE ISSUE, UPON INSPECTING THE OTHER 3 HE BELIEVES THEM TO NOT BE RIGHT AS WELL

Additional Manufacturer Narrative

A COMPLAINT WAS RECEIVED INVOLVING A CIRCUMCISION CLAMP THAT REPORTEDLY WHEN TIGHTENING THE NUT THE METALS TOUCHED.. NO LONG-TERM COMPLICATIONS OR SERIOUS INJURY HAVE BEEN REPORTED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME. FOLLOW-UP ACTIVITIES ARE ONGOING TO OBTAIN THE DEVICE AND ADDITIONAL INFORMATION RELATED TO THE EVENT.