MalfunctionNBH

STRATOS ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM

Received Jun 22, 2018 · Event occurred Jun 11, 2018

Report MW5078016 · MDR key 7633692

Device

Generic name

Accessories, Arthroscopic

Manufacturer

A.m. Surgical, Inc.

Model number

REF 5500

Lot number

0218R

Product problems

Break

Patient

36 YR

No Known Impact Or Consequence To Patient
No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

DURING SCHEDULED ENDOSCOPIC CARPAL TUNNEL RELEASE, ATTEMPTING TO USE STRATOS DEVICE WHEN BLADE TIP OF DEVICE BROKE OFF IN DEVICE CHANNEL. DEVICE REMOVED, 2ND STRATOS DEVICE OPENED, MD CHOSE NOT TO PROCEED WITH DEVICE WHEN UNABLE TO GET INTO SAME TISSUE PLANE. PROCEEDED WITH OPEN CARPAL TUNNEL RELEASE; COMPLETED WITHOUT INCIDENT.