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.
[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
| Report Number | 1219930-2020-01465 |
| MDR Report Key | 9908572 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2018-09-28 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA HERNANDEZ |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | COVIDIEN LP LLC NORTH HAVEN |
| Manufacturer Street | 195 MCDERMOTT RD |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06473 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRI-STAPLE 2.0 |
| Generic Name | STAPLE, IMPLANTABLE |
| Product Code | GDW |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-02-17 |
| Model Number | SIGTRS45AXT |
| Catalog Number | SIGTRS45AXT |
| Lot Number | N8J1017X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP LLC NORTH HAVEN |
| Manufacturer Address | 195 MCDERMOTT RD NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |