MAUDE Adverse Event Report: A.M. SURGICAL INC. STRATOS; ACCESSORIES, ARTHROSCOPIC

Model Number 5500

Device Problem Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/14/2018

Event Type  malfunction  

Event Description

Stratos blade used and fired during endoscopic carpal tunnel release procedure.Blade stayed in patient upon pulling out of procedure.

• Brand Name: STRATOS
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): A.M. SURGICAL INC. ; 222 middle country road; suite 202; smithtown NY 11787
• MDR Report Key: 7613452
• MDR Text Key: 111713871
• Report Number: MW5077925
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: 5500
• Device Lot Number: 0817R
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1