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

Model Number OMS-T10SB

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2022

Event Type  malfunction  

Event Description

Patient undergoing surgical procedure, suture structural balloon trocar ruptured during inflation.

• Brand Name: AUTO SUTURE
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 15851591
• MDR Text Key: 304187089
• Report Number: 15851591
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2022

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: OMS-T10SB
• Device Catalogue Number: OMS-T10SB
• Device Lot Number: P2D0324
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19710 DA
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White