MAUDE Adverse Event Report: COVIDIEN COVIDIEN ENDO PADDLE RETRACT; RETRACTOR

Model Number	173046
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was having a laparoscopic procedure.During the procedure, an endo paddle retractor was being used.When the paddle retractor was removed, it was noticed that a 3mm piece from the end of it was missing.The piece is a semitransparent white plastic button-shaped piece.The decision was made to leave the piece in the patient after retrieval could not be confirmed after attempts.There is currently no apparent injury to the patient related to the retained item.Fda safety report id# (b)(4).

• Brand Name: COVIDIEN ENDO PADDLE RETRACT
• Common Device Name: RETRACTOR
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 13111386
• Report Number: MW5106328
• Device Sequence Number: 4485683
• Product Code: GAD
• UDI-Device Identifier: 10884523000771
• UDI-Public: (01)10884523000771
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/23/2021

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
• Operator of Device: Health Professional
• Device Model Number: 173046
• Device Catalogue Number: 173046
• Device Lot Number: P8E1245X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 170 KG
• Patient Race: Black Or African American