MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-25 for LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER LF1637 manufactured by Covidien Lp.
[36928890]
(b)(4). The incident device has been received and is under evaluation. When the device evaluation is complete a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[36928891]
The customer reported that during a laparoscopic gyn case the ligasure did not seal or burn. The device was recognized by the generator and "appropriate sounds" were heard during activation. There was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[39029392]
(b)(4). Date of follow-up report : 02/25/2016. 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 | 1717344-2016-00063 |
MDR Report Key | 5389605 |
Date Received | 2016-01-25 |
Date of Report | 2015-12-30 |
Date of Event | 2015-12-28 |
Date Mfgr Received | 2016-02-05 |
Date Added to Maude | 2016-01-25 |
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 BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER |
Generic Name | LIGASURE VESSEL SEALING SYSTEM |
Product Code | BWA |
Date Received | 2016-01-25 |
Returned To Mfg | 2016-01-15 |
Model Number | LF1637 |
Catalog Number | LF1637 |
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 | 2016-01-25 |