MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-19 for MARYLAND JAW LAP (37CM) LF1737 manufactured by Covidien Lp.
[46062819]
(b)(4). The site indicated that the incident sample was discarded. If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[46062820]
The customer reported that during a lap-assisted hysterectomy, the device jaws could not be re-opened. A new device of the same type was opened and used to successfully complete the case. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717344-2016-00430 |
| MDR Report Key | 5666291 |
| Date Received | 2016-05-19 |
| Date of Report | 2016-05-13 |
| Date of Event | 2016-05-10 |
| Date Mfgr Received | 2016-05-13 |
| Device Manufacturer Date | 2015-12-17 |
| Date Added to Maude | 2016-05-19 |
| 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 | 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 | 0 |
| Brand Name | MARYLAND JAW LAP (37CM) |
| Generic Name | LIGASURE VESSEL SEALING SYSTEM |
| Product Code | BWA |
| Date Received | 2016-05-19 |
| Model Number | LF1737 |
| Catalog Number | LF1737 |
| Lot Number | 53370166X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-05-19 |