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 2018-05-17 for PREMIUM MULTIFIRE TA 010315 manufactured by Covidien North Haven Lp Llc - Mfg.
[108550163]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[108550164]
According to the reporter, during a left pneumonectomy, while they used the device on the superior pulmonary vein without any problem, they proceeded to apply the instrument on the second left pulmonary vein & activated the instrument. When they wanted to open it, the instrument remained close on the vein. They had to dissect the vein toward the mediastinum to apply a new instrument without any problem. They were the able to take the instrument out of the patient. The procedure was completed without any problem after that. The instrument being returned will be in the close position with the vein segment in it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2018-02695 |
| MDR Report Key | 7522212 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-17 |
| Date of Report | 2018-08-10 |
| Date of Event | 2018-05-09 |
| Date Mfgr Received | 2018-07-26 |
| Device Manufacturer Date | 2013-10-02 |
| Date Added to Maude | 2018-05-17 |
| 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 | 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 NORTH HAVEN LP LLC - MFG |
| 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 | PREMIUM MULTIFIRE TA |
| Generic Name | APPARATUS, SUTURING, STOMACH AND INTESTINAL |
| Product Code | FHM |
| Date Received | 2018-05-17 |
| Returned To Mfg | 2018-06-08 |
| Model Number | 010315 |
| Catalog Number | 010315 |
| Lot Number | N3K0205X |
| Device Expiration Date | 2018-10-31 |
| 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 NORTH HAVEN LP LLC - MFG |
| Manufacturer Address | 195 MCDERMOTT RD NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-17 |