MalfunctionPTS

VERSA GRASP

Received Apr 20, 2026 · Event occurred Apr 9, 2026

Report MW5186967 · MDR key 24926414

Device

Generic name

Endoscopic Grasping/cutting Instrument, Non-powered, Exempt

Manufacturer

Anrei Medical (hz) Co., Ltd.

Lot number

2025092001

Patient

4 YR · Male

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

A SINGLE-USE GRASPING FORCEPS TIP BROKE OFF DURING A CYSTOSCOPY/STENT REMOVAL PROCEDURE AND WAS FOUND IN THE PATIENT'S BLADDER. THE BROKEN PIECE WAS ABLE TO BE RETRIEVED BY DR. USING A NON-DISPOSABLE GRASPER. THE DISPOSABLE GRASPER AND THE RETRIEVED BROKEN PIECE WERE SENT TO THE LAB FOR EXAMINATION ALONG WITH THE PRODUCT'S PACKAGING. PRODUCT REF NUMBER: M0067802000 / LOT NUMBER: 2025092001.