inforMED
MalfunctionOCW

MiniGrip Clutch Grasper

Received Jul 29, 2026 · Event occurred Jun 16, 2026

Report 3011137372-2026-00251 · MDR key 50071489

Device

Generic name

Endoscopic Tissue Approximatio

Manufacturer

Teleflex Medical

Model number

IPN914232

Catalog number

PGCC300

Lot number

GML-00479

Product problems

  • Break

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

It was reported that during a pediatric surgical procedure, the jaws of a MINIGRIP Semi-Strong Clutch Grasper broke during use. A fragment of the device detached and fell into the surgical site. The surgical team searched for the fragment within the patient and recovered it with difficulty. The grasper was replaced, and the procedure was completed using another device. The event resulted in a prolonged surgical procedure and prolonged anesthesia. No clinical consequences or injury to the patient were reported. The patient was reported to be in fine condition following the procedure.

Additional Manufacturer Narrative

(b)(4).