MAUDE Adverse Event Report: A.M. SURGICAL, INC. STRATOS ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM; ACCESSORIES, ARTHROSCOPIC

Lot Number 0318R

Device Problems Display or Visual Feedback Problem (1184); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/15/2018

Event Type  malfunction  

Event Description

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.

• Brand Name: STRATOS ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): A.M. SURGICAL, INC. ; smithtown NY 11787
• MDR Report Key: 7540413
• MDR Text Key: 109378208
• Report Number: MW5077426
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/21/2018

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: 03/31/2020
• Device Lot Number: 0318R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2018
• 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