MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-31 for LIGASURE IMPACT LF4318 manufactured by Covidien Lp.
[35248022]
(b)(4). The incident sample and additional information has been requested but to date has not been received. 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
[35248023]
The customer reported that there was random self-activation with the device. Another device was used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[40745027]
(b)(4). Date of follow-up report: 03/18/2016. One used lf4318 was received, and evaluation of the returned sample could not confirm the reported issue. Visual inspection of the device found no defects. Testing was performed on simulated tissue, and all seals were completed successfully with end tones that were heard each time indicating completed activation cycles. The investigation found the device to function normally and within specifications. A review of the device history records for this lot found no potentially contributing entries to the reported issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2015-00944 |
| MDR Report Key | 5338671 |
| Date Received | 2015-12-31 |
| Date of Report | 2015-12-15 |
| Date of Event | 2015-11-13 |
| Date Mfgr Received | 2016-03-16 |
| Device Manufacturer Date | 2014-12-02 |
| Date Added to Maude | 2015-12-31 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 LP |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGASURE IMPACT LF4318 |
| Generic Name | LIGASURE VESSEL SEALING SYSTEM |
| Product Code | BWA |
| Date Received | 2015-12-31 |
| Returned To Mfg | 2016-03-15 |
| Model Number | LF4318 |
| Catalog Number | LF4318 |
| Lot Number | 43220071X |
| Device Expiration Date | 2019-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-31 |