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 05/11/2017

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.Post market vigilance (pmv) led an evaluation of one device and reload.The event report alleges the product was used in a surgical procedure.There were no visual or functional abnormalities observed during the product analysis.The stapler was loaded with a pmv device loading unit and fired on the test media with acceptable staple formation.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 component related failures; therefore, a device history record will not be performed.Our investigation was unable to determine a root cause or establish a relationship between the device and the reported incident.Based on the evidence available the reported condition was not confirmed.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

Event Description

According to the reporter, during a hernia repair procedure, the staples were not closing.There was no patient injury.

• 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 avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6811476
• MDR Text Key: 83313598
• Report Number: 2647580-2017-06183
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521070575
• UDI-Public: 20884521070575
• 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
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 174023
• Device Catalogue Number: 174023
• Device Lot Number: P7B0422X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2017
• 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