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

Model Number 174023

Device Problem Failure to Form Staple (2579)

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

Event Date 06/22/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a hernia repair, the stapler did not lock (fold/close) properly.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance led an evaluation of one device.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Based on the evidence available the reported condition was confirmed.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MULTIFIRE VERSATACK
• 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 ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6911116
• MDR Text Key: 88046454
• Report Number: 2647580-2017-06971
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521070578
• UDI-Public: 10884521070578
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 174023
• Device Catalogue Number: 174023
• Device Lot Number: P6J0544X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/06/2017
• Initial Date FDA Received: 10/03/2017
• Supplement Dates Manufacturer Received: 11/22/2017
• Supplement Dates FDA Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2016
• 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