MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-10 for ULTRA-CATCH NT (1.8 FR X 115 CM) STONE RETRIEVAL DEVICE NT4W18115 manufactured by Gyrus Acmi, Inc.
[97796854]
The referenced device will not be returned to olympus for evaluation as it was discarded after the procedure. The exact cause of the reported event cannot be determined; however, the mostly likely cause of the reported event can be attributed to a higher than normal force applied on the joint by the operator when extracting a large stone. The instruction manual warns users: certain objects may be too large to remove endoscopically with this retrieval system. To avoid complications fluoroscopic x-ray or some means of identification of an objects size should be used prior to attempting to remove. Do not use this device if the object is too large to be removed and/or cannot be securely held in the stone dislodger. Inspect the device for any visible damage such as kinks or broken stone dislodger wires. Test the device by opening, closing and rotating it several times before being introduced into the patient.
Patient Sequence No: 1, Text Type: N, H10
[97796855]
The user facility informed olympus that while performing a stone retrieval the basket separated from the wire and fell into the patient. It was reported that the basket was retrieved. It is unknown if the intended procedure was completed. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00011 |
| MDR Report Key | 7180771 |
| Date Received | 2018-01-10 |
| Date of Report | 2018-01-10 |
| Date of Event | 2017-12-15 |
| Date Mfgr Received | 2017-12-17 |
| Date Added to Maude | 2018-01-10 |
| 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. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-512 |
| 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 | 2018-01-10 |
| Model Number | NT4W18115 |
| Catalog Number | NT4W18115 |
| Lot Number | UNKNOWN |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-01-10 |