MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-18 for LIGASURE ADVANCE PISTOL GRIP LF5544 manufactured by Covidien Lp.
[38997449]
(b)(4). Date of initial report : 02/18/2016. The sample has been requested but to date the incident sample has not been received for evaluation. 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
[38997450]
The customer reported that the jaws were not able to be re-opened during the procedure. There was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[40149696]
(b)(4). Date of follow-up report : 03/11/2016. Visual inspection found no defects. The product jaws were not stuck shut. The jaws opened and closed normally when the handle was activated. The knife extended and retracted normally when the trigger was activated. The investigation found the device to function normally and within specifications. Manufacturing non-conformances were reviewed. No entries pertinent to the customer's report were noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2016-00149 |
| MDR Report Key | 5444059 |
| Date Received | 2016-02-18 |
| Date of Report | 2016-01-25 |
| Date Mfgr Received | 2016-03-03 |
| Device Manufacturer Date | 2015-10-14 |
| Date Added to Maude | 2016-02-18 |
| 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 | 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 ADVANCE PISTOL GRIP |
| Generic Name | LIGASURE VESSEL SEALING SYSTEM |
| Product Code | BWA |
| Date Received | 2016-02-18 |
| Returned To Mfg | 2016-02-26 |
| Model Number | LF5544 |
| Catalog Number | LF5544 |
| Lot Number | 52740048X |
| 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 | 2016-02-18 |