MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-31 for TRI-STAPLE 2.0 SIGTRS45AXT manufactured by Covidien Lp Llc North Haven.

Event Text Entries

[185976201] Evaluation summary: post market vigilance (pmv) led an evaluation of one device. Visual inspection of the returned product noted that the reload was fully fired. Microscopic evaluation noted that the reload had damage to the cutting edge of the knife blade. Functionally, the reload was loaded into a post market vigilance instrument, the interlock was overridden, and the reload was cycled without hesitation or binding. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Additionally, the investigation detected a unreported condition of knife blade damage. Replication of the damaged knife blade may occur when an obstacle has been incorporated in the jaws during application. The information booklet which accompanies each product shipment cautions the user; ensure that no obstructions (such as clips) are incorporated in the instrument jaws. Firing over an obstruction may result in incomplete cutting action and/or improperly formed staples. The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition. No further actions have been deemed necessary at this time. There was no reported condition to confirm. Additionally, an unreported condition of knife blade damage was confirmed. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10

[185976202] According to the reporter, during a wedge segmental resection procedure, at first firing, when the power handle and the reinforcement were connected, the screen display became strange wherein the zone display could not be checked on the incongruous display that is divided in four. The firing was done without issue. However, on the second firing, the same issue occurred with the display when the tissue was clamped. And the device did not fire. Re-setting was performed from the adapter but the issue persist. A manual handle was used to complete the procedure. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number1219930-2020-01465
MDR Report Key9908572
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-01-28
Date Mfgr Received2020-03-13
Device Manufacturer Date2018-09-28
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLISA HERNANDEZ
Manufacturer Street60 MIDDLETOWN AVE
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034925563
Manufacturer Street195 MCDERMOTT RD
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal Code06473
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRI-STAPLE 2.0
Product CodeGDW
Date Received2020-03-31
Returned To Mfg2020-02-17
Model NumberSIGTRS45AXT
Catalog NumberSIGTRS45AXT
Lot NumberN8J1017X
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
Manufacturer Address195 MCDERMOTT RD NORTH HAVEN CT 06473 US 06473


Patient NumberTreatmentOutcomeDate
10 2020-03-31

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