MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-31 for LIGASURE LF1923 manufactured by Covidien Mfg Dc Boulder.
[185708550]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185708551]
According to the reporter, intra-operatively, when passing about 2 hours after it was started to be used, the device being used became not to work. A new like device was used and it worked fine. There was no bleeding occurred. It was noted that the regrasp alert was unknown, but there was a sealing tone and end tone. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[188580830]
Evaluation summary: one device was received for evaluation. Functional testing was performed with the returned device on porcine kidney tissue. Multiple seals on various size vessels were made and a full thermal effect was visually verified. The device was activated while pressing the button and with the rotation knob in various positions to detect any problematic activation issues. All seal cycles were completed satisfactorily and end tones were heard indicating completed activation cycles. The investigation found the device to function normally and within specifications. The instructions for use(ifu) states, keep the instrument jaws clean. Build up of eschar may reduce sealing and/or cutting effectiveness. Wipe jaw surfaces and edges with a wet gauze pad as needed. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2020-00364 |
| MDR Report Key | 9902494 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-11-20 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2019-08-30 |
| Date Added to Maude | 2020-03-31 |
| 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 | LISA HERNANDEZ |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | COVIDIEN MFG DC BOULDER |
| Manufacturer Street | 5920 LONGBOW DR |
| Manufacturer City | BOULDER CO 803013299 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 803013299 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGASURE |
| Generic Name | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
| Product Code | GEI |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-30 |
| Model Number | LF1923 |
| Catalog Number | LF1923 |
| Lot Number | 92180107X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MFG DC BOULDER |
| Manufacturer Address | 5920 LONGBOW DR BOULDER CO 803013299 US 803013299 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |