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

Model Number 174025

Device Problems Detachment Of Device Component (1104); Failure to Form Staple (2579)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/22/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturer reference number: (b)(4).This event was originally reported on a quarterly summary report and is being resubmitted per fda request.

Event Description

According to the reporter: during a hernia procedure under coeiliscopic technique, a component disengaged.There was poor staple formation.The staple does not totally close.There was no patient harm.The patient status is alive, no injury.

• Brand Name: MULTIFIRE ENDO HERNIA
• 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: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6813090
• MDR Text Key: 83510568
• Report Number: 2647580-2017-06200
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521070599
• UDI-Public: 20884521070599
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K912097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 174025
• Device Catalogue Number: 174025
• Device Lot Number: P5J0650X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1