MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO UNIVERSAL 65; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 173054

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 11/11/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, post operatively, the patient was discharged following a laparoscopic inguinal hernia repair, the doctor used the device to secure the mesh and replaced the load with another one to close the peritoneum in the first hospital.They inserted a nasal gastric tube for decompression.There was no improvement and the patient was transferred to a second hospital for management and the patient was operated by a laparoscopic lysis of adhesion and removal of the device on the distal small bowel and was sutured to correct a small bowel obstruction due to a metal device clamped down on the small bowel.The patient received preoperative intravenous antibiotics and was under general anesthesia.The patient was hospitalized for five days at the first hospital and four days at the second hospital.There was patient injury.

• Brand Name: ENDO UNIVERSAL 65
• 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: 8297939
• MDR Text Key: 134766919
• Report Number: 2647580-2019-00637
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521070530
• UDI-Public: 10884521070530
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K912097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173054
• Device Catalogue Number: 173054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2019
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 59