MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-11 for PREMIUM MF TA* 30-V3 TITANIUM STAPLER 010315 manufactured by Covidien, Formerly Us Surgical A Divison.
[59754185]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[59754186]
According to the reporter: during a thoracic procedure, the doctor attempted to fire the device on 2 occasions resulting in bleeding. Stapler deployment was incomplete, resulting in only partial ligation of the pulmonary vein. The doctor subsequently ligated the remainder of the pulmonary vein with prolene suture to achieve hemostasis. The patient was transferred to pacu in stable condition after surgery.
Patient Sequence No: 1, Text Type: D, B5
[63762575]
Patient Sequence No: 1, Text Type: N, H10
[68785845]
(b)(4). Post market vigilance (pmv) led an evaluation of one premium mf ta 30-v3 titanium stapler and two premium mf ta 30-v3 titanium dlu. This evaluation was based on a medical and technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends and an evaluation of the returned device. The jaws were open. The sulus were fully fired; one sulu had two malformed staple. The sulus were reloaded with staples. The instrument and sulus were fired over test media with acceptable staple formation. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219930-2016-01182 |
| MDR Report Key | 6096464 |
| Date Received | 2016-11-11 |
| Date of Report | 2016-10-19 |
| Date Mfgr Received | 2017-01-30 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2016-11-11 |
| 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 AVENUE |
| 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 | 2016-11-11 |
| Returned To Mfg | 2016-12-06 |
| Model Number | 010315 |
| Catalog Number | 010315 |
| Lot Number | N4F0438X |
| Device Expiration Date | 2019-06-30 |
| 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 | 2016-11-11 |