MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-03-18 for LINA BIPOLAR LOOP BL-160 manufactured by Lina Medical Polska Sp. Z.o.o.
[16779859]
Doctor ignited the bipolar loop and it began cutting. About 1/8 of the way through the cervix the loop broke at the electrode.
Patient Sequence No: 1, Text Type: D, B5
[17003958]
Most possible reason of the loop break is bending of the wire in a way that it didn't stand the pressure and the heat at the same time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007699067-2014-00003 |
| MDR Report Key | 3770331 |
| Report Source | 08 |
| Date Received | 2014-03-18 |
| Date of Event | 2013-09-30 |
| Date Mfgr Received | 2013-10-02 |
| Device Manufacturer Date | 2013-03-01 |
| Date Added to Maude | 2014-05-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANNE KLITGARD |
| Manufacturer Street | FORMERVANGEN 5 |
| Manufacturer City | GLOSTRUP 00002600 |
| Manufacturer Country | DA |
| Manufacturer Postal | 00002600 |
| Manufacturer G1 | LINA MEDICAL POLSKA SP. Z.O.O |
| Manufacturer Street | UL.ROLNA 8 SADY |
| Manufacturer City | TARNOWO PODGORNE 0000 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 0000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LINA BIPOLAR LOOP |
| Generic Name | BIPOLAR LOOP |
| Product Code | HIN |
| Date Received | 2014-03-18 |
| Model Number | BL-160 |
| Lot Number | 13111 |
| Device Expiration Date | 2016-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINA MEDICAL POLSKA SP. Z.O.O |
| Manufacturer Address | SADY TARNOWO, PODGORNE 0000 PL 0000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-18 |