MAUDE Adverse Event Report: A. M. SURGICAL, INC. SMITHTOWN NY 11787 ULTRA ENDOSCOPIC RELEASE SYSTEM; ACCESSORIES, ARTHROSCOPIC

Model Number 2400

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2022

Event Type  Injury  

Event Description

The patient was undergoing carpal tunnel surgery and a piece of plastic from an endoscopic release system's cutting guide cannula sheared off into the patient requiring conversion to an open procedure.The piece came off when the blade was advanced along the slot that the cutting blade travels back and forth in.The blade got too close to the side of the plastic cannula edge as it was advance and the plastic sheared off.We think at least two factors contributed to this: blade does not seem to lock into the sheath in limited positions, and can rotate into the edge of the sheath; plastic sheath was surprisingly soft and easily cut.Fda safety report id#: (b)(4).

• Brand Name: ULTRA ENDOSCOPIC RELEASE SYSTEM
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): A. M. SURGICAL, INC. SMITHTOWN NY 11787; 285 middle country rd; suite 206; smithtown NY 11787
• Manufacturer Contact: vincent pascale
• MDR Report Key: 16432834
• MDR Text Key: 310135034
• Report Number: 3001617730-2022-00001
• 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: Manufacturer
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2400
• Device Lot Number: 0522C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention