MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-11 for MARYLAND JAW LAP (37CM) LF1737 manufactured by Covidien Lp.
[38604458]
(b)(4). Date of initial report : 02/11/2016. 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
[38604459]
The customer reported that the sealing function did not work well during a laparoscopic gastrectomy.
Patient Sequence No: 1, Text Type: D, B5
[41233495]
(b)(4). 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 | 1717344-2016-00127 |
| MDR Report Key | 5430212 |
| Date Received | 2016-02-11 |
| Date of Report | 2016-01-14 |
| Date Mfgr Received | 2016-03-10 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2016-02-11 |
| 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 | MARYLAND JAW LAP (37CM) |
| Generic Name | LIGASURE VESSEL SEALING SYSTEM |
| Product Code | BWA |
| Date Received | 2016-02-11 |
| Returned To Mfg | 2016-02-04 |
| Model Number | LF1737 |
| Catalog Number | LF1737 |
| Lot Number | 50780166X |
| 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 | 2016-02-11 |