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.
[185978980]
Evaluation summary: post market vigilance (pmv) led an evaluation of one device. Visual inspection of the instrument noted damage to an internal transistor. The piezo did not sound upon initialization. Analysis of the system logs showed that the battery charge cycle count had exceeded the charge cycle limit. An analysis of the system logs also 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. 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. As the battery charge cycles increase battery full charge capacity decreases. To ensure the battery has sufficient full charge capacity to complete a surgical case the powered handle is rendered unusable at 300 battery charge cycles. Additionally, the investigation detected a unreported condition of a damaged internal transistor that has no relationship to the reported condition. Replication of the damaged electrical components resulting in loss of piezo function may occur due to rough handling such as the handle being dropped. This failure poses no patient safety risk. The audible tones are for user information only and do not communicate patient safety related issues. No further actions have been deemed necessary at this time. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185978981]
According to the reporter, prior a thoracic wedge segmental resection procedure, it was noted that the signia handle indicator which was being charged, illuminated red. Even if it was reinserted again and the charger was replaced, the situation did not improve. The handle displayed the error mark. Another device was used. There was no patient involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219930-2020-01439 |
| MDR Report Key | 9904386 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-10-15 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2017-11-29 |
| 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 | 2019-11-11 |
| 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 |