MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-07-09 for ENDOSCOPIC BIPOLAR LOOP FOR LSH, 200X100MM BL-200 manufactured by Lina Medical Polska Sp. Z.o.o.
[6832514]
"allegedly, after looping the bipolar loop around the uterus, the doctor went to pull back on the handle to get the loop snug around the uterus. However, the entire handle came apart and began to spark. "
Patient Sequence No: 1, Text Type: D, B5
[14209283]
Lina medical polska sp z o. O. - the manufacturer is currently waiting for the product to be returned and investigated, shipment is arranged by the logistics department.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007699067-2015-00004 |
| MDR Report Key | 4908362 |
| Report Source | 08 |
| Date Received | 2015-07-09 |
| Date of Report | 2015-07-07 |
| Date of Event | 2015-03-26 |
| Date Mfgr Received | 2015-06-12 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2015-08-04 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOANNA MADAJSKA |
| Manufacturer Street | FORMERVANGEN 5 |
| Manufacturer City | GLOSTRUP DK-2600 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-2600 |
| Manufacturer Phone | 12225009 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOSCOPIC BIPOLAR LOOP FOR LSH, 200X100MM |
| Generic Name | ENDOSCOPIC BIPOLAR LOOP |
| Product Code | HIN |
| Date Received | 2015-07-09 |
| Model Number | BL-200 |
| Catalog Number | BL-200 |
| Lot Number | 14201 |
| Device Expiration Date | 2017-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | ROLNA 8A SADY TARNOWO PODGORNE 62-080 PL 62-080 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-09 |