MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-16 for LIGASURE ATLAS HANDSWITCHING 20CM LS1020 manufactured by Covidien Llc (shanghai).
[31477851]
(b)(4). To date, the incident sample has not been received for evaluation, and the lot number is not specified. 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
[31477852]
The customer reported via medwatch form (b)(4), that during a sigmoid colectomy a burn occurred near the incision site of the ligasure device. The generator energy level was set at two bars, and the burn was reported as not serious. The patient did not need to see a wound care specialist and the degree was not identified.
Patient Sequence No: 1, Text Type: D, B5
[34091763]
(b)(4). No sample was returned for investigation, and the complaint could not be confirmed. Review of the relevant device history records found no potentially pertinent entries that could have contributed to the reported issue, and no trend is associated with this complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2015-00812 |
| MDR Report Key | 5225662 |
| Date Received | 2015-11-16 |
| Date of Report | 2015-11-13 |
| Date Mfgr Received | 2015-11-18 |
| Date Added to Maude | 2015-11-16 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 LLC (SHANGHAI) |
| Manufacturer Street | BLDG. 10, 789 PUXING RD. |
| Manufacturer City | SHANGHAI |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGASURE ATLAS HANDSWITCHING 20CM |
| Generic Name | LIGASURE VESSEL SEALING SYSTEM |
| Product Code | BWA |
| Date Received | 2015-11-16 |
| Model Number | LS1020 |
| Catalog Number | LS1020 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LLC (SHANGHAI) |
| Manufacturer Address | BLDG. 10, 789 PUXING RD. SHANGHAI CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-16 |