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.
[185802402]
Evaluation summary: post market vigilance (pmv) led an evaluation of one device. An analysis of the system logs noted that towards the end of the logs, the handle was placed on a charger. The next time the handle initializes is with low voltage detected on the charger, a low relative state of charge value, and low individual cell voltages. The handle was opened up and both batteries were found to be vented. The battery was replaced with a known working one and the handle powered on. After the handle turned on, it was noted that the screen was dim. A clamshell was attached to the device and held out at an arms length. The handle was then tilted upwards at a thirty degree angle. The screen was not very visible when held in this manner. The logs were evaluated and there were no abrupt or sudden ends to logs with no restart command, indicating that the cause of dim screen was not due to an esd event or an abrupt shutdown of the power handle. A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture. The root cause of the device not charging was determined to be a result of a software fault. The battery cells vented, causing them to leak electrolytic fluid. The battery cells would be unable to charge under these circumstances and would result in the handle entering a cell under voltage state. Improvements have been initiated to mitigate this condition. The root cause of the dim display was determined to be a result of a component failure. However, the cause of this specific failure could not be reliably determined. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185802403]
According to the reporter, prior an esophagectomy procedure, the display of the reported handle was noted to be darker when compared with the other. It was stated that sales representative removed the reported handle from the charger, the charger illuminated green but the display was in a status of being charged less than a half. As the situation was not improved even if trying for several times, the event was reported. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2020-01456 |
| MDR Report Key | 9905378 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-10-28 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2018-01-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2019-11-13 |
| 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 |