MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-11 for LINA BIPOLAR LOOP BL-160 manufactured by Lina Medical Aps.
[72345862]
Patient Sequence No: 1, Text Type: N, H10
[72345863]
During first case the lina loop was used after severing the cervix and the loop was removed. Doctor noticed that wire was exposed. Rep was present. During last case the same thing happened. Doctor told rep he did not want to use the lina loop until they fixed this issue. No patient complication; able to complete both cases without issue. Called into company. Sent back for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6479669 |
| MDR Report Key | 6479669 |
| Date Received | 2017-04-11 |
| Date of Report | 2017-04-04 |
| Date of Event | 2017-03-20 |
| Report Date | 2017-04-04 |
| Date Reported to FDA | 2017-04-04 |
| Date Reported to Mfgr | 2017-04-04 |
| Date Added to Maude | 2017-04-11 |
| 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 | 3 |
| 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 BIPOLAR LOOP |
| Generic Name | COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES) |
| Product Code | HIN |
| Date Received | 2017-04-11 |
| Returned To Mfg | 2017-03-20 |
| Model Number | BL-160 |
| Catalog Number | BL-160 |
| Lot Number | 14351 |
| Device Expiration Date | 2017-08-01 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINA MEDICAL APS |
| Manufacturer Address | 816 CONGRESS AVENUE SUITE 1400 AUSTIN TX 78701 US 78701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-11 |