inforMED
MalfunctionHFX

CENTURION

Received May 8, 2026 · Event occurred Apr 10, 2026

Report 1824619-2026-00011 · MDR key 25125629

Device

Generic name

Circlamp W/1.1cm Bell (st)

Catalog number

310CR

Lot number

2025102401

Product problems

  • Unintended Movement

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, THE "BELL COMES OFF OF THE REMAINING FORESKIN VERY EASILY" CAUSING "SOME CASES OF INCREASED BLEEDING" DUE TO THE BELL NOT "GETTING THE "CRUSH" INJURY THAT IT SHOULD GET". THE CUSTOMER REPORTED THAT "AT THIS POINT THERE WAS NO ADVERSE EVENT", AND NO INJURY HAS OCCURRED. THE CUSTOMER REPORTED THAT THERE WAS NO FOLLOW-UP CARE, MEDICAL, AND/OR SURGICAL INTERVENTION OR TREATMENT REQUIRED RELATED TO THE REPORTED ISSUE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

ACCORDING TO THE CUSTOMER, THE "BELL COMES OFF OF THE REMAINING FORESKIN VERY EASILY" CAUSING "SOME CASES OF INCREASED BLEEDING" DUE TO THE BELL NOT "GETTING THE "CRUSH" INJURY THAT IT SHOULD GET".

Additional Manufacturer Narrative

UPDATE TO H6: INVESTIGATION FINDINGS.