MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-31 for SIGNIA SIGPHANDLE manufactured by Covidien Lp Llc North Haven.
[186005080]
Evaluation summary: post market vigilance (pmv) led an evaluation of one device. Analysis of the system logs showed no abnormalities in oled functionality, but multiple battery communication errors are clearly shown. The rear housing was removed and there was damage to the 44-pin flex cable on the ground pins where it connects to the motor board. A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture. The ground trace on 44-pin flex cable become damaged due to the rear handle housing pushing against the flex cable. Damage to the ground pins can result in a continuous reset due to an intermittent connection. Improvements have been initiated to mitigate this condition. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186005081]
According to the reporter during an esophagectomy, prior to use of the device, the handle was removed from the charger. After the handle was started up normally, the handle was set with the power shell, and on the screen, the unusable indication appeared, an x-mark with red circle. Therefore, it was unable to be used. Another handle and a new power shell was taken out. The surgery was continued. The event occurred during the procedure but the product was not used for patient. There was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2020-01458 |
| MDR Report Key | 9905473 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-08-05 |
| Date Mfgr Received | 2020-03-20 |
| Device Manufacturer Date | 2018-10-24 |
| Date Added to Maude | 2020-03-31 |
| 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 | SIGNIA |
| Generic Name | STAPLE, IMPLANTABLE |
| Product Code | GDW |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2019-08-27 |
| Model Number | SIGPHANDLE |
| Catalog Number | SIGPHANDLE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-31 |