MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-13 for LIGASURE ADVANCE PISTOL GRIP LF5544 manufactured by Covidien Lp.
[36099086]
(b)(4). Date of initial report : 01/13/2016. The incident device has been received and is under evaluation. When the device evaluation is complete a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[36099087]
The customer originally reported that during a total laparoscopic-assisted hysterectomy the device knife could no longer be activated. There was no patient injury. The device was returned for evaluation with the clear insulation near the jaws torn and two webs (sharp) protruding from the cleavis area.
Patient Sequence No: 1, Text Type: D, B5
[41350960]
(b)(4). The knife did not advance when the trigger was activated and it was found that the knife was hitting the back of the blue jaw seal plate. This can happen when the user places excessive tension on the jaws, forcing them out of alignment. The ifu cautions the user to 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. When the knife contacted the back of the seal plate, the trigger was forced and this caused the webbing to protrude. The webbing was sharp. The ifu states to gently pull the cutting trigger to engage the cutting mechanism. Furthermore, the clear insulation was damaged but all pieces were still attached. The device failed hipot testing. The ifu states to prevent damage to the flexible insulation proximal to the jaws, confirm the handle is fully closed prior to insertion into and extraction from the cannula. Use the appropriately sized cannula to allow for easy insertion and extraction of the instrument. Failure to do so may impact the integrity of the flexible insulation. Cannulas with hard, non-beveled openings may cause the flexible insulation to retract, which may compromise the insulation. If retraction occurs, the instrument must be discarded. Do not attempt to clean the flexible insulation. Cleaning may damage insulation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2016-00035 |
| MDR Report Key | 5363465 |
| Date Received | 2016-01-13 |
| Date of Report | 2016-01-13 |
| Date of Event | 2015-12-21 |
| Date Mfgr Received | 2016-03-09 |
| Device Manufacturer Date | 2015-11-27 |
| Date Added to Maude | 2016-01-13 |
| 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 | 2016-01-13 |
| Returned To Mfg | 2016-01-13 |
| Model Number | LF5544 |
| Catalog Number | LF5544 |
| Lot Number | 33110328X |
| Device Expiration Date | 2018-11-30 |
| 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 | 2016-01-13 |