MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-24 for MARYLAND JAW LAP (37CM) LF1737 manufactured by Covidien Lp.
[32227834]
(b)(4). Date of initial report : 11/24/2015. 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
[32227835]
The customer reported that during a video-assisted thoracoscopic surgery procedure, the surgeon was sealing dividing right lung tissue and the tip of the device got stuck and it could not be separated from the tissue. The surgeon used a hook bovie device to remove the tissue from the device tip. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
[36811772]
Covidien reference # : (b)(4). Date of follow-up report : 01/25/2016. The returned product met specification as received. The investigation found dried blood on the seal plate. The device was activated on a porcine tissue with satisfactory results. All seal cycles were completed satisfactorily and end tones were heard indicating completed activation cycles. The jaws opened and closed properly when testing the latch mechanism. The jaws did not stick to the tissue. The investigation found the device to function normally and within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2015-00820 |
| MDR Report Key | 5246243 |
| Date Received | 2015-11-24 |
| Date of Report | 2015-11-13 |
| Date of Event | 2015-11-13 |
| Date Mfgr Received | 2015-12-23 |
| Device Manufacturer Date | 2015-10-20 |
| Date Added to Maude | 2015-11-24 |
| 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 | MARYLAND JAW LAP (37CM) |
| Generic Name | LIGASURE VESSEL SEALING SYSTEM |
| Product Code | BWA |
| Date Received | 2015-11-24 |
| Returned To Mfg | 2015-12-07 |
| Model Number | LF1737 |
| Catalog Number | LF1737 |
| Lot Number | 52750118X |
| 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 | 2015-11-24 |