MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-02-08 for PREMIUM MF TA* 30-V3 TITANIUM STAPLER 010315 manufactured by Covidien, Formerly Us Surgical A Divison.
[66778902]
(b)(4). User facility listed in initial reporter.
Patient Sequence No: 1, Text Type: N, H10
[66778903]
According to the reporter: occurred during a liver transplant procedure. The jaws would not open and the device had to be cut out on the portal vein. Resulted in smaller margins of the portal vein for transplant, tissue loss. After the procedure, the device was able to be opened, but the button was jammed.
Patient Sequence No: 1, Text Type: D, B5
[69353844]
Ftr#(b)(4). Udi#(b)(4). Post market vigilance (pmv) led an evaluation of three staplers. The instruments were received open; each loaded with a fully fired 2. 5mm sulu. A piece of tissue was observed stuck to the anvil of one instrument. The staples in the tissue were properly formed. The cartridges were reloaded with staples. The instruments and sulus were applied to appropriate test media with proper staple formation. Visual and functional testing of the returned product confirmed the product, as received, met specifications. Product analysis indicates that the devices were used in a surgical procedure. A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture. The product analysis concluded there were no device abnormalities that would have caused or contributed to the reported incident. No enhancements or improvements were generated for the reported condition. The tissue attached to the anvil, indicated that the instrument was not properly used during the procedure. However there is not enough evidence to determine what improper use occurred. Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219930-2017-00154 |
| MDR Report Key | 6310368 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-02-08 |
| Date of Report | 2017-01-11 |
| Date of Event | 2017-01-11 |
| Date Mfgr Received | 2017-02-23 |
| Device Manufacturer Date | 2016-07-01 |
| Date Added to Maude | 2017-02-08 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN, FORMERLY US SURGICAL A DIVISON |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| 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 | PREMIUM MF TA* 30-V3 TITANIUM STAPLER |
| Generic Name | APPARATUS, SUTURING, STOMACH AND INTESTINAL |
| Product Code | FHM |
| Date Received | 2017-02-08 |
| Returned To Mfg | 2017-02-08 |
| Model Number | 010315 |
| Catalog Number | 010315 |
| Lot Number | N6G0400X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY US SURGICAL A DIVISON |
| Manufacturer Address | 60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-02-08 |