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

Model Number 174025

Device Problems Failure to Form Staple (2579); Mechanics Altered (2984)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during a laparoscopic gastric bypass, when closing the mesenteric defect, when the first staple was fired it came out an angle and stuck in the device.It was removed with an artery clip then the stapler was fired again on the outside of body and was found that all the fired staples were malformed.A new stapler was used to complete the case.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the instrument noted the e-piece was partially disengaged from the device on one side.There was evidence of weld on the device.One tack was received jammed in the e piece.The single use loading unit (sulu) was received preloaded on the instrument with one tack remaining.Visual inspection of the instrument noted the e-piece was partially disengaged from the device on one side.There was evidence of weld on the device.One tack was received jammed in the e piece.The sulu was received preloaded on the instrument with one tack remaining.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the reported condition may occur as a result of excessive manipulation of the device.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.No fur ther actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• 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: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 9733196
• MDR Text Key: 180192898
• Report Number: 2647580-2020-00647
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521070592
• UDI-Public: 10884521070592
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K912097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 174025
• Device Catalogue Number: 174025
• Device Lot Number: P9J1171Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2019
• 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 Age: 47 YR