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 |