MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-22 for LIGASURE ADVANCE PISTOL GRIP LF5544 manufactured by Covidien Lp.
[39138362]
(b)(4). Date of initial report : 02/22/2016. The sample has been requested but 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
[39138363]
The customer reported that the jaws of the device would not open after activation. There was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[42810727]
(b)(4). One used (b)(4) was received for evaluation. Visual inspection found the knife is trapped and contained within the jaws. The customer reported that he jaw was unable to be opened after activation. The reported condition was confirmed. The investigation found the jaws were stuck shut due to the knife is trapped and contained within the jaws. The knife did not extend or retract when the trigger was activated. 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 investigation identified the root cause of the reported event to be user error. The ifu states: the ifu cautions: do not turn the rotation wheel when the handle is fully closed and latched. Product damage may occur. Do not apply force to the shaft of the instrument causing tension or bowing as this could make the knife difficult to deploy and the trigger may not return to its normal position. The ifu states to gently pull the cutting trigger to engage the cutting mechanism. The ifu cautions confirm that the jaws have reached the closed position and are locked (the handle is latched) before activating the cutter.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2016-00169 |
| MDR Report Key | 5452424 |
| Date Received | 2016-02-22 |
| Date of Report | 2016-02-02 |
| Date Mfgr Received | 2016-04-05 |
| Device Manufacturer Date | 2014-04-10 |
| Date Added to Maude | 2016-02-22 |
| 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 | 3 |
| Brand Name | LIGASURE ADVANCE PISTOL GRIP |
| Generic Name | LIGASURE VESSEL SEALING SYSTEM |
| Product Code | BWA |
| Date Received | 2016-02-22 |
| Returned To Mfg | 2016-03-30 |
| Model Number | LF5544 |
| Catalog Number | LF5544 |
| Lot Number | 40860083X |
| Device Expiration Date | 2019-03-31 |
| 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 | 2016-02-22 |