MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-28 for LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER LF1637 manufactured by Covidien Lp.
[37240464]
(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
[37240505]
The customer reported that burns were noticed by the physician on the colic loop of the patient. The tissue appeared to be damaged. There was no bleeding.
Patient Sequence No: 1, Text Type: D, B5
[40350933]
(b)(4). Date of follow-up report : 03/14/2016. The reported condition was not confirmed. The device could not be tested for activation because the cord had been cut off prior to evaluation. No activation was possible. The jaws were clean and there were no signs of arcing. The investigation could not determine the root cause of the customer's report. 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 | 1717344-2016-00092 |
| MDR Report Key | 5397194 |
| Date Received | 2016-01-28 |
| Date of Report | 2016-01-05 |
| Date of Event | 2015-12-16 |
| Date Mfgr Received | 2016-03-01 |
| Device Manufacturer Date | 2015-03-10 |
| Date Added to Maude | 2016-01-28 |
| 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 | 2016-01-28 |
| Returned To Mfg | 2016-01-21 |
| Model Number | LF1637 |
| Catalog Number | LF1637 |
| Lot Number | 50180139X |
| 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 | 2016-01-28 |