MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-23 for LINA GOLD LOOP EL-200-8 manufactured by Lina Medical Aps.
[118405824]
The defective device has not been returned to manufacturer. Information from distributor is that they have not been able to retrieve the product yet. The nurse said that it was either thrown away or passed on to risk management, who has not responded to our inquiries. So we are still waiting for the final decision.
Patient Sequence No: 1, Text Type: N, H10
[118405825]
Dr. (b)(6) was using the lina gold loop and the patients right external iliac artery was nicked. Via 2nd hand info, a nurse said that the loop broke, but it's unclear what specifically was meant by the term "broke". The nurse did not know the generator type, nor the generator settings. When asked if the uterine manipulator was possibly left in place, the nurse did not know, but said the surgeon had experience using the loop previously.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007699067-2018-00002 |
| MDR Report Key | 7808256 |
| Date Received | 2018-08-23 |
| Date of Report | 2018-10-01 |
| Date of Event | 2018-07-18 |
| Date Facility Aware | 2018-07-20 |
| Date Mfgr Received | 2018-07-23 |
| Device Manufacturer Date | 2016-10-10 |
| Date Added to Maude | 2018-08-23 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MONIKA LEWANDOWSKA |
| Manufacturer Street | LINA MEDICAL APS FORMERVANGEN 5 |
| Manufacturer City | GLOSTRUP, DENMARK DK-2600 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-2600 |
| Manufacturer G1 | LINA MEDICAL POLSKA SP. Z O. O. |
| Manufacturer Street | ROLNA 8A, SADY TARNOWO PODG |
| Manufacturer City | SADY, POLAND 62-080 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62-080 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LINA GOLD LOOP |
| Generic Name | LINA GOLD LOOP, LARGE, PRODUCT CODE: KNF |
| Product Code | KNF |
| Date Received | 2018-08-23 |
| Model Number | EL-200-8 |
| Catalog Number | EL-200-8 |
| Lot Number | 1642011 |
| Device Expiration Date | 2019-10-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINA MEDICAL APS |
| Manufacturer Address | FORMERVANGEN 5 GLOSTRUP,, DENMARK DK2600 DA DK2600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-23 |