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.
[32225320]
(b)(4). To date the incident sample has not been received for evaluation. If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[32225321]
The customer reported that during a laparoscopic colon procedure, the device jaws were sticking together and not completely opening all the way. There was no patient injury. The site contact was not able to provide additional details regarding the device and incident.
Patient Sequence No: 1, Text Type: D, B5
[37467380]
(b)(4). Date of follow-up report : 02/04/2016. The returned product met specification as received. Visual inspection found no defects. The jaws opened and closed normally when the handle was activated. The knife extended and retracted normally when the trigger was activated. The investigation found the device to function normally and within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2015-00845 |
| MDR Report Key | 5246414 |
| Date Received | 2015-11-24 |
| Date of Report | 2015-11-19 |
| Date of Event | 2015-11-18 |
| Date Mfgr Received | 2016-01-06 |
| Device Manufacturer Date | 2015-09-03 |
| 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 | MS 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 | 3 |
| Brand Name | LIGASURE ADVANCE PISTOL GRIP |
| Generic Name | LIGASURE VESSEL SEALING SYSTEM |
| Product Code | BWA |
| Date Received | 2015-11-24 |
| Returned To Mfg | 2015-12-07 |
| Model Number | LF5544 |
| Catalog Number | LF5544 |
| Lot Number | 52180076X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | 5920 LONGBOW DRIVE BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-24 |