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

Model Number	TA3048L
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a lobectomy procedure, while preparing to divide the bronchial bronchus, the device did not fire, squeezing of the handle was not complete, handle did not return to the open position, and did not remain in the closed position following the second complete squeeze of the handle.A new device was used in order to complete the case.No patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The sulu contained the full complement of staples.Since the clinical instrument was not received, a pmv representative instrument was used for all functional testing.The loading unit was loaded into the representative instrument and applied to test media.The staple line was properly formed.However, the reported condition can occur when the user mistakes the tactile pre-clamp feature for the full firing stroke.This feature allows the handle to be released, without returning to its original position, for final positioning of the tissue.After the tissue is properly positioned, the handle stroke must be continued to full clamp position.Staples will only fire after the fully clamped handle returns to its original position and is squeezed a second time.Unfortunately, since the clinical instrument was not received, a full functional evaluation could not be performed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.Additional information:d10 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: 6873467
• Report Number: 2647580-2017-06687
• Device Sequence Number: 16446440
• Product Code: GDW
• UDI-Device Identifier: 10884521043121
• UDI-Public: 10884521043121
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2017

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: 06/30/2020
• Device Model Number: TA3048L
• Device Catalogue Number: TA3048L
• Device Lot Number: P5F0377X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR