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.
[185798205]
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 logs also showed error: handle, hw_error and sd_card_integrity indicating an sd card failure. The handle was opened up and both batteries were found to be vented. 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 observed condition 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. Additionally, the investigation detected a unreported condition of an sd card integrity error that has no relationship to the reported condition. The system performs sd card integrity check as part of system initialization. This is the only time the check is performed. As a result, the system will fail safely prior to assembly with a clamshell or adapter and poses no patient safety risk. A cross functional team has reviewed the risk and rate of occurrence for this failure mode and has determined that no corrective actions are warranted at this time. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185798206]
According to the reporter, prior the procedure, the handle was being charged in the operation preparation room, but it was found that the red indicator of the charger illuminated. When the handle was removed from the charger to check the situation, liquid scorched part was found at the terminal part of the charger, so charging was stopped after that. When the reported product was collected and checked, although the charger was connected to the outlet, the red indicator flashed. When the handle was connected to a charger that had no problem, it was noted that the indicator flashed green indicating that the handle was being charged, but when the handle was removed from the charger after a while, it could not start up. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2020-01443 |
| MDR Report Key | 9904530 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-09-13 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2018-06-12 |
| 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 | 2019-10-08 |
| 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 |