MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2017-02-07 for PREMIUM MF TA* 30-V3 TITANIUM STAPLER 010315 manufactured by Covidien, Formerly Us Surgical A Divison.
[66721542]
Manufacturer reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[66721543]
According to the reporter, during a liver transplant, the jaws would not open and the device had to be cut out on the portal vein. Resulted in smaller margins. The product was not re-sterilized prior to this incident. The complaint product was used on a patient. There was unanticipated tissue loss due to the device having to be cut off tissue. Resulted in smaller margin in portal vein for transplant.
Patient Sequence No: 1, Text Type: D, B5
[69355444]
(b)(4). Evaluation summary: post market vigilance (pmv) led an evaluation of eleven devices. One instrument was received open, loaded with a fully fired sulu. The remaining ten instruments were received sealed in the blister packages. All eleven instruments were received with the jaws open. The instrument received open was 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. A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture. 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 | 1219930-2017-00150 |
| MDR Report Key | 6308705 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2017-02-07 |
| Date of Report | 2017-01-11 |
| Date of Event | 2016-12-15 |
| Date Mfgr Received | 2017-02-08 |
| Device Manufacturer Date | 2016-07-01 |
| Date Added to Maude | 2017-02-07 |
| 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 | 2017-02-07 |
| 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 | 2017-02-07 |