MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-12 for LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER LF1637 manufactured by Covidien Lp.
[36063691]
(b)(4). 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
[36063692]
The customer reported that the device was used successfully 20 times and then the device did not seem to be sealing as expected and no steam was visible. End tones, indicating a complete seal cycle, were provided by the generator in use. Another device of the same type was opened and used to complete the case. There was no bleeding or patient injury.
Patient Sequence No: 1, Text Type: D, B5
[39117255]
(b)(4). Date of initial report : 01/12/2016. Date of follow-up report : 02/24/2016. The incident device was returned, evaluated and found to function within specification. The device was tested for activation and sealing function on simulated tissue with acceptable results. Additional testing was done by performing multiple seals of various sizes on porcine tissue and all seal cycles were completed satisfactorily. Covidien was unable to confirm the customer? S report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2016-00034 |
| MDR Report Key | 5360602 |
| Date Received | 2016-01-12 |
| Date of Report | 2015-12-28 |
| Date of Event | 2015-12-23 |
| Date Mfgr Received | 2016-02-05 |
| Device Manufacturer Date | 2015-07-20 |
| Date Added to Maude | 2016-01-12 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER |
| Generic Name | LIGASURE VESSEL SEALING SYSTEM |
| Product Code | BWA |
| Date Received | 2016-01-12 |
| Returned To Mfg | 2016-01-21 |
| Model Number | LF1637 |
| Catalog Number | LF1637 |
| Lot Number | 51520299X |
| 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 | 2016-01-12 |