MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-22 for LINA GOLD LOOP EL-240-8 manufactured by Lina Medical Polska Sp. Z O. O..
[34803442]
Manufacturer - lina medical (b)(4) is correctly waiting for the product to be evaluated. Lot number of the defective device was not provided in the complaint report hence no data regarding the manufacturing date and expiration date is available. Device not returned to manufacturer yet.
Patient Sequence No: 1, Text Type: N, H10
[34803443]
The wire on the gold loop broke preventing amputation of the uterus from the cervix. A second loop was opened to complete the amputation. The manufacturer opened a complaint file and asked follow-up questions. Manufacturer intends to send a shipping label for the device to be returned for a full investigation. What was the original intended procedure? Laparoscopic supracervical hysterectomy. Device usage problem: device failed (e. G. Broke, couldn't get it to work or stopped working).
Patient Sequence No: 1, Text Type: D, B5
[36811350]
Patient Sequence No: 1, Text Type: N, H10
[36811351]
The wire on the gold loop broke preventing amputation of the uterus from the cervix. A second loop was opened to complete the amputation. The manufacturer opened a complaint file and asked follow-up questions. Manufacturer intends to send a shipping label for the device to be returned for a full investigation. What was the original intended procedure? Laparoscopic supracervical hysterectomy device usage problem: device failed (e. G. Broke, couldn't get it to work or stopped working).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007699067-2015-00008 |
| MDR Report Key | 5317646 |
| Date Received | 2015-12-22 |
| Date of Report | 2016-01-25 |
| Date of Event | 2015-10-30 |
| Report Date | 2015-12-07 |
| Date Reported to Mfgr | 2015-12-07 |
| Date Mfgr Received | 2015-12-07 |
| Date Added to Maude | 2015-12-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JOANNA MADAJSKA |
| Manufacturer Street | ROLNA 8A, SADY TRANOWO PODG |
| Manufacturer City | 62-080 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-080 |
| Manufacturer Phone | 12225009 |
| Manufacturer G1 | LINA MEDICAL APS |
| Manufacturer Street | FORMERVANGEN 5 |
| Manufacturer City | GLOSTRUP, DK2600 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | DK2600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LINA GOLD LOOP |
| Generic Name | COAGULATOR-CUTTER, ENDOSCOPIC |
| Product Code | HIN |
| Date Received | 2015-12-22 |
| Returned To Mfg | 2015-12-29 |
| Model Number | EL-240-8 |
| Catalog Number | EL-240-8 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINA MEDICAL POLSKA SP. Z O. O. |
| Manufacturer Address | ROLNA 8A, SADY TARNOWO PODG?RNE SADY, 62-080 PL 62-080 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-22 |