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

Model Number	015485L
Medical Device Problem Codes	Failure to Form Staple (2579); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: health professional (hpro).(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a mechanical anastomosis on an open procedure, the device was difficult or unable to close.The device also had an incomplete staple line.They had to oversew to fix the staple line and another mechanical anastomosis was done to complete the case.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a mechanical anastomosis on an esophageal resection, the device had an incomplete staple line although a full squeeze has been performed.They had to oversew to fix the staple line and another mechanical anastomosis was done to complete the case.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the loading unit noted that all the staples were partially advanced in the cartridge.The staples were in unusable unformed condition.The pusher slots that did not have partially advanced staples were not loaded with any staples.Functionally, the loading unit was reloaded with staples.Since an instrument was not received a pmv representative instrument was used for functional evaluation.The pmv instrument and loading unit were applied to test media with proper 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.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.Replication of the advanced staple condition may occur when the firing stroke is not completed during application.The instructions for use of this product state: to fire the instrument, squeeze the handle a second time until it reaches a solid stop and it locks in the back position.If the instrument handle is partially squeezed during firing then released, bleeding may occur as the instrument was not fully fired.The current packaging design for the product does not allow room for advanced staples, thus the condition could not have occurred during assembly or shipment.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a mechanical anastomosis on an esophageal resection, the device had an incomplete staple line although a full squeeze has been performed.They had to oversew to fix the staple line and another mechanical anastomosis was done to complete the case.

• Brand Name: TA PREMIUM
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 7793341
• Report Number: 2647580-2018-04120
• Device Sequence Number: 1293257
• Product Code: GDW
• UDI-Device Identifier: 10884521047433
• UDI-Public: 10884521047433
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K855047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 015485L
• Device Catalogue Number: 015485L
• Device Lot Number: P8B0925X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Initial Date Received by Manufacturer: 08/02/2018
• Supplement Date Received by Manufacturer: 08/20/2018; 09/24/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 09/06/2018; 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR