inforMED
MalfunctionNBH

STRATOS

Received Jun 18, 2018 · Event occurred Jun 14, 2018

Report MW5077925 · MDR key 7613452

Device

Generic name

Accessories, Arthroscopic

Manufacturer

A.m. Surgical Inc.

Model number

5500

Lot number

0817R

Product problems

  • Entrapment of Device

Patient

Not reported

  • Device Embedded In Tissue or Plaque
  • Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

STRATOS BLADE USED AND FIRED DURING ENDOSCOPIC CARPAL TUNNEL RELEASE PROCEDURE. BLADE STAYED IN PATIENT UPON PULLING OUT OF PROCEDURE.