inforMED
MalfunctionNBH

STRATOS ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM

Received May 23, 2018 · Event occurred May 15, 2018

Report MW5077426 · MDR key 7540413

Device

Generic name

Accessories, Arthroscopic

Lot number

0318R

Product problems

  • Display or Visual Feedback Problem
  • Device Operates Differently Than Expected

Patient

Not reported

  • No Patient Involvement
  • No Patient Involvement

Narrative

Description of Event or Problem

UNABLE TO ENGAGE STRATOS ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM DEVICE. DEVICE SAID "SCOPE" MODE BUT WAS STUCK IN "SCRAPER" MODE. SURGEON UNABLE TO USE. DEVICE NEVER USED ON PATIENT. NEVER PLACED AT/ON THE STERILE FIELD. SALES REPRESENTATIVE NOTIFIED; AWAITING CALL BACK FOR DISPOSITION OF DEVICE.