MalfunctionKDD

MOGEN CLAMP

Received Apr 9, 2026 · Event occurred Apr 4, 2026

Report MW5186618 · MDR key 24834717

Device

Generic name

Kit, Surgical Instrument, Disposable

Manufacturer

Bioseal

Model number

MOGEN CLAMP

Lot number

1644

Product problems

Difficult to Open or Close
Therapeutic or Diagnostic Output Failure

Patient

2 DA · Male

Hemorrhage/Blood Loss/Bleeding

Narrative

Description of Event or Problem

THE BIOSEAL MOGEN CLAMP NOT CLOSING COMPLETELY AT THE END OF CIRCUMCISION LEADING TO UNEXPECTED BLEEDING. THIS HAPPENED IN SIX OUT OF 8 PATIENTS UNDERGOING CIRCUMCISION. PT: 1888. DEVICE: 2921, 3023. REF: MW5186616, MW5186617, MW5186619, MW5186620, MW5186621.