MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-16 for FLEX CATCH NT 1.9 FR (0.64 MM) X 115 CM NT4F19115 manufactured by Gyrus Acmi, Inc..
[183517548]
The doctor was conducting a basket cysto ureteroscopy laser stone extraction stent placement. The basket malfunctioned halfway during the case and will not open and close properly. The basket was replaced, increasing operative cost and time, potentially putting the patient at risk. Additionally, the laser fiber tip degraded far prior to its expected life. This is a repeated pattern with this product line and the company. Manufacturer response for laser fiber, (brand not provided) (per site reporter). Waiting for reply from sales man. Manufacturer response for stone retrieval device, flex catch nt 1. 9 fr (0. 64 mm) x 115 cm (per site reporter). The clinicians contacted the sales rep and we are waiting for a response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9835107 |
| MDR Report Key | 9835107 |
| Date Received | 2020-03-16 |
| Date of Report | 2020-01-23 |
| Date of Event | 2020-01-22 |
| Report Date | 2020-02-25 |
| Date Reported to FDA | 2020-02-25 |
| Date Reported to Mfgr | 2020-03-16 |
| Date Added to Maude | 2020-03-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEX CATCH NT 1.9 FR (0.64 MM) X 115 CM |
| Generic Name | DISLODGER, STONE, FLEXIBLE |
| Product Code | FGO |
| Date Received | 2020-03-16 |
| Model Number | NT4F19115 |
| Catalog Number | NT4F19115 |
| Lot Number | 91904080 |
| Device Availability | Y |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | 9600 LOUISIANA AVE NORTH BROOKLYN PARK MN 55445 US 55445 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |