GOMCO
Received Jun 12, 2026 · Event occurred Jun 2, 2026
Report 1924066-2026-00008 · MDR key 25487645
Device
Generic name
500s Circ. Clamp Ex Small 1.1
Manufacturer
Allied Medical Llc.Model number
02-00-0500Catalog number
02-00-0500
Lot number
UNKNOWN
Product problems
- Insufficient Device Problem Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A COMPLAINT WAS RECEIVED INVOLVING A CIRCUMCISION CLAMP THAT REPORTEDLY CUT THE TISSUE ITSELF DURING USE. 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.
Description of Event or Problem
WHEN THE PEDIATRICIAN CLAMPED DOWN THE DEVICE IT CUT THE TISSUE ITSELF, HE ONLY HAD TO CUT ABOUT 1 MILLIMETRE HIMSELF. THERE WERE NO INJURIES TO THE PATIENT.