MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-11 for NEW LIGASURE 5MM LF1537 manufactured by Covidien Lp.
[38604482]
(b)(4). Date of initial report : 02/11/2016 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
[38604483]
The customer stated that jaw of the device would not open during the procedure. There was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717344-2016-00129 |
| MDR Report Key | 5430330 |
| Date Received | 2016-02-11 |
| Date of Report | 2016-01-20 |
| Date of Event | 2016-01-20 |
| Date Mfgr Received | 2016-01-20 |
| Device Manufacturer Date | 2014-12-24 |
| Date Added to Maude | 2016-02-11 |
| 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 | 0 |
| Brand Name | NEW LIGASURE 5MM |
| Generic Name | LIGASURE VESSEL SEALING SYSTEM |
| Product Code | BWA |
| Date Received | 2016-02-11 |
| Model Number | LF1537 |
| Catalog Number | LF1537 |
| Lot Number | 43280146X |
| Device Expiration Date | 2019-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-02-11 |