MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-02 for ULTRA-CATCH NT (1.8 FR X 115 CM) STONE RETRIEVAL DEVICE NT4W18115 manufactured by Gyrus Acmi, Inc.
[76724894]
At the time of this report, the device has not yet been returned for evaluation. As a result, a determination cannot be made at this time. If further information becomes available, gyrus acmi will continue the investigation and update the agency accordingly.
Patient Sequence No: 1, Text Type: N, H10
[76724895]
The basket of nt4w18115 stone retrieval device has fallen in the kidney of the patient and had to be recovered. The hospital has recovered the basket.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011050570-2017-00002 |
| MDR Report Key | 6609276 |
| Date Received | 2017-06-02 |
| Date of Report | 2017-10-03 |
| Date Mfgr Received | 2017-09-28 |
| Date Added to Maude | 2017-06-02 |
| 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 | MR TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 508804-273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ULTRA-CATCH NT (1.8 FR X 115 CM) STONE RETRIEVAL DEVICE |
| Generic Name | STONE RETRIEVAL DEVICE |
| Product Code | FGO |
| Date Received | 2017-06-02 |
| Model Number | NT4W18115 |
| Lot Number | MK643255 |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-06-02 |