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

Model Number 2400

Device Problems Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008); Device Fell (4014)

Patient Problems Laceration(s) (1946); Foreign Body In Patient (2687)

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
• MDR Report Key: 15595781
• MDR Text Key: 301757077
• Report Number: MW5112583
• 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: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American