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

Model Number 173054

Device Problems Loss of or Failure to Bond (1068); Failure to Form Staple (2579)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2020

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 inguinal hernia repair procedure, the devices were able to fire, but staples did not close completely and hold on tissue.Another reload was used to complete the case.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.Visual inspection of the both product noted no abnormalities.Both instruments were received with a partially applied single use loading unit (sulu) preloaded on the device.The articulation and rotation knobs of both instruments functioned properly.The first instrument was applied to the appropriate test media.The remaining ten staples deployed and seated properly in the appropriate test media.The second instrument was applied to the appropriate test media.The remaining six staples deployed and seated properly in the appropriate test media.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• 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: 9869612
• MDR Text Key: 184732114
• Report Number: 2647580-2020-01038
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521070530
• UDI-Public: 10884521070530
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 173054
• Device Catalogue Number: 173054
• Device Lot Number: P9D1564Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2019
• 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