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

Model Number OMS-T10BT

Device Problems Inflation Problem (1310); Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, pre-operatively, there was a leakage at the balloon and couldn¿t be ballooned for test.The device was changed with new product to continue.There was no patient involvement.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) received one device.The visual inspections noted that the inflation port was cracked.The balloon, lock collar, valve seal and doors appeared intact.The obturator and inflation bulb were received.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly or component related failures.Replication of the broken insufflation port may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 8203975
• MDR Text Key: 131713116
• Report Number: 2647580-2018-06348
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521080874
• UDI-Public: 10884521080874
• Combination Product (y/n): N
• PMA/PMN Number: K924011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: OMS-T10BT
• Device Catalogue Number: OMS-T10BT
• Device Lot Number: P8A1201X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Date Manufacturer Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1