MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for LIGASURE LF2019 manufactured by Covidien Lp.
[185521283]
Patient was brought to the operation room for a needle-guided partial mastectomy of the left breast. General anesthesia was administered. When the dissector was checked, the team noted that the machine did not detect the device. The device was changed with another one; this time it worked and the procedure was done without any further event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9896889 |
| MDR Report Key | 9896889 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-03-03 |
| Report Date | 2020-03-13 |
| Date Reported to FDA | 2020-03-13 |
| Date Reported to Mfgr | 2020-03-30 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | 2020-03-30 |
| Model Number | LF2019 |
| Catalog Number | LF2019 |
| Lot Number | 93290207X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |