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

Model Number OMS-T10SB

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, laparoscopic bilateral inguinal hernia, two balloons would not inflate.The bulb inflation device was used to pump air into the balloon to inflate it but the doctor was unable to pump and inflate the balloon.The second and third product were opened to complete the surgery.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: 10556963
• MDR Text Key: 207704475
• Report Number: 2647580-2020-03034
• 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: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: OMS-T10SB
• Device Catalogue Number: OMS-T10SB
• Device Lot Number: P0E0350Y
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2020
• Date Device Manufactured: 05/04/2020
• 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
• Patient Age: 44 YR