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

Model Number	015458L
Medical Device Problem Codes	Failure to Form Staple (2579); Mechanics Altered (2984)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/27/2018
Type of Reportable Event	Serious Injury
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 open rectum surgery, the staples did not deploy at the end of the procedure.There was also poor staple formation.The staple line was fixed by over sew and colostomy was done in order to complete the case.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the 4.8mm sulu noted that all the staples were partially advanced in the cartridge.The staples were in usable unformed condition.Since the clinical instrument was not received a pmv representative instrument was use for testing.The representative instrument and the sulu were applied to appropriate test media.The jaw closes smoothly, and the handle actuates smoothly into the clamped position.The jaw opens, handle unlocks, and pin slide retracts when release button is depressed.Acceptable staple formation was observed on test media.A review of the device history record indicates this product was 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.

• 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: 7374342
• Report Number: 2647580-2018-01561
• Device Sequence Number: 19122930
• Product Code: GDW
• UDI-Device Identifier: 20884521047409
• UDI-Public: 20884521047409
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K855047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

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: 02/28/2022
• Device Model Number: 015458L
• Device Catalogue Number: 015458L
• Device Lot Number: P7B0579X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 11/20/2018
• 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