MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-08 for LIGASURE ADVANCE PISTOL GRIP LF5544 manufactured by Covidien Lp.
[38239191]
(b)(4). Date of initial report : 02/08/2016. Visual inspection found the knife is trapped and contained within the jaws. The jaws were stuck shut due to the knife is trapped and contained within the jaws. Knife trap happens when the blade is extended and the jaws are not completely closed. This allows the knife track to open too wide and the blade moves out of its track. As a safety measure, the knife must be retracted in order to open the jaws. The tissue in the webbing may have prevented the knife from retracting far enough to allow the jaws to open. More frequent cleaning could have also reduced the difficulty activating the knife. The ifu cautions confirm that the jaws have reached the closed position and are locked (the handle is latched) before activating the cutter. Manufacturing non-conformances were reviewed. No entries pertinent to the report were noted.
Patient Sequence No: 1, Text Type: N, H10
[38239192]
The customer reported that the jaws of the device stopped opening wide during a laparoscopic colon procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717344-2016-00115 |
| MDR Report Key | 5417608 |
| Date Received | 2016-02-08 |
| Date of Report | 2016-01-12 |
| Date of Event | 2016-01-11 |
| Date Mfgr Received | 2016-01-12 |
| Device Manufacturer Date | 2015-09-01 |
| Date Added to Maude | 2016-02-08 |
| 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 |
| Manufacturer G1 | COVIDIEN LP |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80301 |
| 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 | 2016-02-08 |
| Returned To Mfg | 2016-01-21 |
| Model Number | LF5544 |
| Catalog Number | LF5544 |
| Lot Number | 52180076X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2016-02-08 |