MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO GIA; STAPLE, IMPLANTABLE

Model Number 030422

Device Problems Unintended Arm Motion (1033); Unintended Movement (3026)

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

Event Date 11/24/2017

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 the second firing on the stomach on a laparoscopic gastric bypass procedure, the jaws opened and then close then the stapler start to move without commands.There was a problem loading the reload onto the adaptor also.The handle did not recognize the reload.The stapler did not fire.The surgeon was not able to press the green button and squeeze the handle.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the returned product noted that the loading unit was fully fired.Functionally the loading unit was loaded into a pmv representative instrument and was cycled without hesitation or binding.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.

Event Description

According to the reporter, during the second firing on the stomach on a laparoscopic gastric bypass procedure, the jaws opened and then close then the stapler start to move without commands.There was a problem loading the reload onto the adaptor also.The handle did not recognize the reload.The stapler did not fire.The surgeon was not able to press the green button and squeeze the handle.It was substituted for another reload in order to complete the case.There was no patient injury.

• Brand Name: ENDO GIA
• Type of Device: STAPLE, IMPLANTABLE
• 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: 7203784
• MDR Text Key: 97799890
• Report Number: 2647580-2018-00355
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523002973
• UDI-Public: 10884523002973
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 030422
• Device Catalogue Number: 030422
• Device Lot Number: P5A0083X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2015
• 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: 33 YR
• Patient Weight: 117