MAUDE Adverse Event Report: COVIDIEN ENDO PADDLE RETRACTOR; RETRACTOR

Model Number 173046

Device Problems Break (1069); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2020

Event Type  malfunction  

Event Description

Did not deploy, when removed broke in half - all pieces removed - no issue to pt.Fda safety report id# (b)(4).

• Brand Name: ENDO PADDLE RETRACTOR
• Type of Device: RETRACTOR
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 9882921
• MDR Text Key: 185223442
• Report Number: MW5093929
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/24/2020

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 Model Number: 173046
• Device Catalogue Number: 173046
• Device Lot Number: P9A1233Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2020
• 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
• Patient Age: 53 YR