MAUDE Adverse Event Report: COVIDIEN LLC AUTO SUTURE BLUNT TIP TROCAR 12MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number OMS-T12BT

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2019

Event Type  Injury  

Event Description

Covidien autosuture blunt tip trocar 12mm used during case upon removal portions of the plastic sleeve was found to be missing.Pieces removed.Fda safety report id# (b)(4).

• Brand Name: AUTO SUTURE BLUNT TIP TROCAR 12MM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LLC; mansfield MA 02048
• MDR Report Key: 8981416
• MDR Text Key: 158352205
• Report Number: MW5089648
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521081093
• UDI-Public: (01)10884521081093
• 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: 09/05/2019

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: 03/31/2022
• Device Model Number: OMS-T12BT
• Device Catalogue Number: OMS-T12BT
• Device Lot Number: P9D0009Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 38 YR