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 2018-02-20 for PREMIUM MULTIFIRE TA 010315- manufactured by Covidien Lp Llc North Haven.
[100522918]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[100522919]
According to the reporter, during an open thoracoscopic lobectomy procedure when the device applied on vessel, the device was difficult/unable to open. The device would not open after clamped over the tissue. It was removed using additional tool. Surgical time was extended more than 30 minutes. The surgeon took the instrument apart in order to complete the case. There was no patient injury. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[113084052]
Evaluation summary: post market vigilance (pmv) led an evaluation of one device. The visual inspection of the returned product noted the instrument was received disassembled and damaged. The loading unit was fully applied. Four properly formed staples were received. The condition of the instrument precludes functional evaluation. The root cause of the observed condition was not identified due to the amount of damage to the received device; however, the manner in which this failure occurred could not be reliably determined with the information available. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Analysis concluded there were no assembly component related failures. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[117480379]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219930-2018-00945 |
| MDR Report Key | 7284312 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-20 |
| Date of Report | 2018-07-03 |
| Date of Event | 2018-01-14 |
| Date Mfgr Received | 2018-06-18 |
| Device Manufacturer Date | 2014-10-24 |
| Date Added to Maude | 2018-02-20 |
| 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 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 | PREMIUM MULTIFIRE TA |
| Generic Name | APPARATUS, SUTURING, STOMACH AND INTESTINAL |
| Product Code | FHM |
| Date Received | 2018-02-20 |
| Returned To Mfg | 2018-03-19 |
| Model Number | 010315- |
| Catalog Number | 010315- |
| Lot Number | N4K1230X |
| Device Expiration Date | 2019-10-31 |
| 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 LP LLC NORTH HAVEN |
| Manufacturer Address | 195 MCDERMOTT RD NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-20 |