MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-24 for LIGASURE ADVANCE PISTOL GRIP LF5544 manufactured by Covidien Lp.
[32227278]
(b)(4). Date of initial report: (b)(6) 2015. The site indicated that the incident sample was discarded. If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[32227279]
The customer reported that during use, the device jaws could not be re-opened and the knife of the instrument could not be advanced or retracted. This occurred during the last half of the surgery. Another device of the same type was opened and used to successfully complete the case. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717344-2015-00837 |
| MDR Report Key | 5246154 |
| Date Received | 2015-11-24 |
| Date of Report | 2015-11-20 |
| Date of Event | 2013-11-01 |
| Date Mfgr Received | 2015-11-20 |
| Date Added to Maude | 2015-11-24 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925267 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIGASURE ADVANCE PISTOL GRIP |
| Generic Name | LIGASURE VESSEL SEALING SYSTEM |
| Product Code | BWA |
| Date Received | 2015-11-24 |
| Model Number | LF5544 |
| Catalog Number | LF5544 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | 5920 LONGBOW DRIVE BOULDER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-24 |