MAUDE Adverse Event Report: COVIDIEN AUTO SUTURE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number OMS-T10SB

Device Problems Inflation Problem (1310); Defective Device (2588)

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

Event Date 05/27/2020

Event Type  malfunction  

Event Description

Structural balloon trocar 10 mm.Balloon did not inflate and clip would not clip.

• Brand Name: AUTO SUTURE
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 10118523
• MDR Text Key: 193966702
• Report Number: 10118523
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: OMS-T10SB
• Device Catalogue Number: OMS-T10SB
• Device Lot Number: P9M1546Y
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/04/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16790 DA