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 2020-03-30 for LIGASURE LS1500 manufactured by Covidien Medical Products.
[185972474]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185972475]
According to the reporter, during nephrectomy procedure, the tip did not open around the middle stage during the operation, and the blade also stopped advancing. The burnt being adhered was not much. They used another like device and it worked fine. There was no tissue damage and resection needed. The device did not lock on tissue. The procedure was extended in less than 30 minutes. It was noted that the regrasp alert was unknown but the sealing tone was heard. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006451981-2020-00050 |
| MDR Report Key | 9899396 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-09-03 |
| Date Added to Maude | 2020-03-30 |
| 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 MEDICAL PRODUCTS |
| Manufacturer Street | BUILDING 10- NO 789 PUXING ROA |
| Manufacturer City | SHANGHAI 201114 |
| Manufacturer Country | CN |
| Manufacturer Postal Code | 201114 |
| 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 |
| Returned To Mfg | 2020-03-30 |
| Model Number | LS1500 |
| Catalog Number | LS1500 |
| Lot Number | S9JB001X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MEDICAL PRODUCTS |
| Manufacturer Address | BUILDING 10- NO 789 PUXING ROA SHANGHAI 201114 CN 201114 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |