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

Model Number	TA6048L
Medical Device Problem Codes	Failure to Fire (2610); Expulsion (2933)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, while transecting the stomach during an open whipple procedure, the stapler did not fire and was pre-fired.Another reload was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one photo and one device.Visual inspection of the photo depicts the single use loading unit (sulu) with the staples legs pre-fired.Visual inspection of the sulu noted that all of the staples were partially advanced in the cartridge.The staples were in usable unformed condition.Since the clinical instrument was not received for evaluation a pmv representative instrument was used for functional evaluation.Functionally, the advanced staples in the sulu were reused and reset inside the cartridge.The representative instrument and sulu 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.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.The root cause of the observed damage was due to the product not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 9915848
• Report Number: 2647580-2020-01206
• Device Sequence Number: 2596273
• Product Code: GDW
• UDI-Device Identifier: 10884521043220
• UDI-Public: 10884521043220
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: TA6048L
• Device Catalogue Number: TA6048L
• Device Lot Number: P8B1079MX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR