MAUDE Adverse Event Report: US SURGICAL PUERTO RICO AUTO SUTURE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number OMS-T10SB

Device Problems Break (1069); Decrease in Pressure (1490); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic hernia repair, when opening up the pre-peritoneal space with the balloon, the surgeon pumped the balloon for about 15 times and it burst and ruptured within the patient's cavity.The balloon separated from the trocar and went missing.There was a rapid loss of pneumoperitoneum as a result of the event.The missing component of the balloon was retrieved from the patient's cavity with the helped of a more experienced laparoscopic surgeon using laparoscopic graspers.There was no patient injury.

• Brand Name: AUTO SUTURE
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 10394383
• MDR Text Key: 202506018
• Report Number: 2647580-2020-02533
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521081086
• UDI-Public: 10884521081086
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K924011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: OMS-T10SB
• Device Catalogue Number: OMS-T10SB
• Device Lot Number: P0C1154Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1