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.
[32224933]
(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
[32224934]
The customer reported that during a procedure the device jaws could not be re-opened. There was no patient injury or increased surgical time.
Patient Sequence No: 1, Text Type: D, B5
[107759492]
Two devices were received for evaluation. This device had been used in the treatment or diagnosis of a patient. A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident. The returned products did not meet specification as received. The visual inspection found the knives were trapped and contained within the jaws. The jaws would not open or close due to the trapped knife. One device the clear insulation was damaged. The 2nd device the clear insulation was missing and was not returned. The reported condition was confirmed. The knives are 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 investigation identified the root cause of the reported event to be knife trap due to user error. The ifu cautions confirm that the jaws have reached the closed position and are locked (the handle is latched) before activating the cutter. No corrective action is required, because no trend has been identified. An additional failure was found during the investigation; the clear insulation was damaged on one device and missing on the other device. The additional findings did not contribute to the reported condition. The devices failed hipot testing. The investigation identified the root cause of the reported event 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 i nstrument must be discarded. Do not attempt to clean the flexible insulation. Cleaning may damage insulation. If information is provided in the future, a supplemental report will be issued. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2015-00839 |
| MDR Report Key | 5245989 |
| Date Received | 2015-11-24 |
| Date of Report | 2018-04-20 |
| Date of Event | 2015-09-01 |
| Date Mfgr Received | 2015-11-12 |
| Device Manufacturer Date | 2015-03-19 |
| 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 | 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 | 0 |
| Brand Name | LIGASURE ADVANCE PISTOL GRIP |
| Generic Name | LIGASURE VESSEL SEALING SYSTEM |
| Product Code | BWA |
| Date Received | 2015-11-24 |
| Model Number | LF5544 |
| Catalog Number | LF5544 |
| Lot Number | 50570088X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-24 |