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

Model Number EEA31

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 06/12/2018

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 rectal/descending colon anastomosis in low abdominal resection, the stapler was unable to load.The surgeon reported it to be too loose and not clicking.Replaced by new stapler to complete the case.No patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection noted that the anvil of the instrument was not received.Additionally, damage to the staple guide and protruding staples were noted.Functional testing with a pmv anvil showed no abnormalities.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.Additionally, the investigation detected a secondary condition of hand compression incomplete that has no relationship to the reported condition.Replication of the reported condition may occur if the instrument handle compression is not completed or if the instrument is applied against an excessive amount of tissue during the clinical application.Also, the instructions for use of this product states: when firing the stapler, make sure to fully squeeze the instrument handle until the metal underside of the handle contacts the stapler body to the fullest extent.Partial or incomplete handle squeezes may result in unacceptable staple formation and/or incomplete knife cut.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EEA
• 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: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7654596
• MDR Text Key: 112865001
• Report Number: 2647580-2018-03263
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523005554
• UDI-Public: 10884523005554
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: EEA31
• Device Catalogue Number: EEA31
• Device Lot Number: P7K1693KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2017
• 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