MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-10 for LINA GOLD LOOP? EL-200-8 manufactured by Lina Medical Aps.
[88849799]
Patient Sequence No: 1, Text Type: N, H10
[88849800]
The lina loop broke as it was in use. The "stray" end cut through tissue as it was pulled through. Also, a vessel was cut, which resulted in excessive bleeding. This required a emergent call to a surgeon for repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6934505 |
| MDR Report Key | 6934505 |
| Date Received | 2017-10-10 |
| Date of Report | 2017-09-28 |
| Date of Event | 2017-09-25 |
| Report Date | 2017-09-28 |
| Date Reported to FDA | 2017-09-28 |
| Date Reported to Mfgr | 2017-09-28 |
| Date Added to Maude | 2017-10-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LINA GOLD LOOP? |
| Generic Name | COAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR |
| Product Code | KNF |
| Date Received | 2017-10-10 |
| Model Number | EL-200-8 |
| Catalog Number | EL-200-8 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINA MEDICAL APS |
| Manufacturer Address | 2500 BEE CAVE ROAD, BLDG 1, SUITE 300 SUITE 1400 AUSTIN TX 78746 US 78746 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-10-10 |