MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN TA; STAPLE, IMPLANTABLE

Model Number	TA4535L
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2018
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, during a hartman procedure, on the rectum, the device did not fire.They were not able to perform full, complete squeezes of the handle.The handle does not return to the open position following the first full squeeze.The handle remained in the closed position following the second complete squeeze.They fired the instrument and that worked fine, then reload the stapler with a new reload, when they closed the instrument this time the handle did not pull back again so they could not do the second squeeze or firing.They changed the reload and tried again, but the same result, the handle did not pull back after the first closer, so the instrument could not be fired again.They solved the situation by using a new instrument.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.The first 3.5mm single-use loading unit (sulu) was received fully fired.The clinical instrument was received.There were no visual or functional abnormalities noted during pmv testing.The loading unit was reset, reloaded into the clinical instrument and cycled with acceptable results.The second 3.5mm single use loading unit (sulu) was received with a full staple complement.Functionally, the clinical instrument and sulu were applied to test media with proper staple formation.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.Pmv was unable to confirm the reported condition during the evaluation.A review of the device history record could not be performed because the lot number was not provided.However, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality specifications.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: TA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7700359
• Report Number: 1219930-2018-03907
• Device Sequence Number: 921034
• Product Code: GDW
• UDI-Device Identifier: 10884521043169
• UDI-Public: 10884521043169
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2018

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 Model Number: TA4535L
• Device Catalogue Number: TA4535L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 08/06/2018; 08/08/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 08/22/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1