MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-07 for LIGASURE ADVANCE PISTOL GRIP LF5544 manufactured by Covidien Lp.
[40029667]
Covidien reference # : (b)(4). Date of initial report : 03/07/2016. 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
[40029668]
The customer reported that the clear insulation towards the jaws became cracked during the procedure. A new device was opened to complete procedure and there was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[41967478]
(b)(4). One used lf5544 was received for evaluation. Visual inspection found the clear insulation was missing from the device. The insulation piece was not returned. The customer reported that the plastic on end of device cracked during procedure. The reported condition was confirmed. The sample failed hipot testing. The investigation identified the root cause of the investigation findings to be user error. 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 the insulation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2016-00218 |
| MDR Report Key | 5484831 |
| Date Received | 2016-03-07 |
| Date of Report | 2016-02-29 |
| Date of Event | 2016-02-18 |
| Date Mfgr Received | 2016-03-14 |
| Date Added to Maude | 2016-03-07 |
| 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 | 2016-03-07 |
| Returned To Mfg | 2016-03-10 |
| Model Number | LF5544 |
| Catalog Number | LF5544 |
| 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 | 2016-03-07 |