inforMED
MalfunctionHFX

GOMCO

Received Apr 9, 2026 · Event occurred Mar 24, 2026

Report 1924066-2026-00005 · MDR key 24830536

Device

Generic name

500s Circ. Clamp Ex Small 1.1

Model number

02-00-0500

Catalog number

02-00-0500

Lot number

UNKNOWN

Product problems

  • Insufficient Device Problem Information

Patient

NA · Unknown

  • Genital Bleeding

Narrative

Description of Event or Problem

MEDLINE REPORTED THE DOCTOR EXPERIENCED EXCESSIVE BLEEDING FOR THE PATIENT AND WOULD LIKE IT INVESTIGATED .

Additional Manufacturer Narrative

A COMPLAINT WAS RECEIVED INVOLVING A CIRCUMCISION CLAMP ASSOCIATED WITH EXCESSIVE BLEEDING DURING USE. NO LONG-TERM COMPLICATIONS HAVE BEEN REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE REMAINS UNDETERMINED. FOLLOW-UP IS IN PROGRESS TO OBTAIN THE DEVICE AND ADDITIONAL EVENT DETAILS. THIS EVENT IS BEING REPORTED DUE TO THE OCCURRENCE OF EXCESSIVE BLEEDING.