MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-02-03 for ENDOSCOPIC BIPOLAR LOOP BL-200 manufactured by Lina Medical Polska Sp. Z.o.o.
[5568168]
According to (b)(6) the loop split at the loop tip while in use. Allegedly, pieces of the hand pieces also fell off when this happened.
Patient Sequence No: 1, Text Type: D, B5
[12877608]
(b)(4) - the mfr is currently waiting for the product to be returned and investigated, shipment is arranged by the (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007699067-2015-00002 |
| MDR Report Key | 4491415 |
| Report Source | 08 |
| Date Received | 2015-02-03 |
| Date of Report | 2015-02-03 |
| Date Mfgr Received | 2015-01-15 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2015-03-09 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOANNA MADAJSKA |
| Manufacturer Phone | 12225009 |
| Manufacturer G1 | LINA MEDICAL APS |
| Manufacturer Street | FORMERVANGEN 5 |
| Manufacturer City | GLOSTRUP DK-2600 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | DK-2600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOSCOPIC BIPOLAR LOOP |
| Generic Name | ENDOSCOPIC BIPOLAR LOOP |
| Product Code | HIN |
| Date Received | 2015-02-03 |
| Model Number | BL-200 |
| Catalog Number | BL-200 |
| Lot Number | 14123 |
| Device Expiration Date | 2017-03-01 |
| 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 | 2015-02-03 |