MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-01 for LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER LF1637 manufactured by Covidien Lp.
[32531080]
(b)(4). The incident sample has been requested but to date 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
[32531081]
The cusstomer reported that during a transanal transabdominal mesorectal excision procedure, the device jaws did not open. It is unknown if the device jaws were on tissue at that time. No patient injury reported. No tissue loss or damaged tissue reported. No bleeding reported. Another device was used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[38294921]
(b)(4). The reported condition was not confirmed. The investigation found that the jaws of the device were not stuck shut. The jaws were clean with no residual blood or eschar. The handle latch did not function properly. Further investigation found that the trigger pin inside the handle was bent. This occurs when the handle is forced open. It could not be determined how or when this issue occurred. A review of the manufacturing non conformances was completed and indicates all parameters and acceptance criteria for entries potentially pertinent to the customer report were within specified limits at the time of release.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2015-00867 |
| MDR Report Key | 5258352 |
| Date Received | 2015-12-01 |
| Date of Report | 2015-11-27 |
| Date of Event | 2015-11-26 |
| Date Mfgr Received | 2015-12-24 |
| Device Manufacturer Date | 2015-04-30 |
| Date Added to Maude | 2015-12-01 |
| 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 | BOULDER |
| 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 | 2015-12-01 |
| Returned To Mfg | 2015-12-09 |
| Model Number | LF1637 |
| Catalog Number | LF1637 |
| Lot Number | 50880136X |
| 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 | 2015-12-01 |