MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-18 for LIGASURE BLUNT TIP OPEN SEALER/DIVIDER LF1520 manufactured by Covidien Lp.
[39020195]
(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
[39020196]
The customer reported that the device would no longer open after being in the shut position. There was no injury to the patient. Another device was used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[45371813]
(b)(4). Date of follow up report: 05/17/2016. One used lf1520 device was received, and evaluation of the returned sample could not confirm the complaint of difficulty opening. Visual inspection of the used device found no defects, and the jaws were open upon receipt. Mechanical testing confirmed that the jaws opened and closed normally on tissue bundles when using the handle. 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 factors, and that it was released after meeting all quality specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2016-00156 |
| MDR Report Key | 5445331 |
| Date Received | 2016-02-18 |
| Date of Report | 2016-01-28 |
| Date of Event | 2015-12-18 |
| Date Mfgr Received | 2016-05-12 |
| Device Manufacturer Date | 2015-08-27 |
| 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 |
| Reporter Occupation | OTHER CAREGIVERS |
| 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 BLUNT TIP OPEN SEALER/DIVIDER |
| Generic Name | LIGASURE VESSEL SEALING SYSTEM |
| Product Code | BWA |
| Date Received | 2016-02-18 |
| Returned To Mfg | 2016-04-28 |
| Model Number | LF1520 |
| Catalog Number | LF1520 |
| Lot Number | 52120045X |
| 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 |