MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-20 for ULTRA-CATCH NT (1.8 FR X 115 CM) STONE RETRIEVAL DEVICE NT4W18115 manufactured by Gyrus Acmi, Inc.
[131493366]
The device was returned to olympus medical systems corp in (b)(4) for evaluation. A visual inspection of the device found a piece of the basket wires broken. The end of the broken wire appeared to have been melted. The basket does not deploy and retract smoothly and the sheath of the device was kinked. A long clear colored ribbon-like material was returned with the device. The foreign material does not appear to be a component of the device. The cause of the melted basket and the resistance the user's experienced is unknown. The olympus sales representative further reported that during the middle of the procedure, the basket was deployed inside the patient without issue. There was no unusual behavior from the device or equipment prior to the reported event. The intended procedure was completed. The cause of the reported event cannot be confirmed, however, olympus will continue to investigate. If additional information becomes available, this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[131493367]
Olympus was informed that during a transurethral lithotripsy procedure, the physician felt resistance when the device is being retracted. The tip of the device was then inspected subsequent to the procedure, and a coating like material appeared to have been peeled off. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00775 |
| MDR Report Key | 8187882 |
| Date Received | 2018-12-20 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-10-15 |
| Date Mfgr Received | 2018-11-20 |
| Date Added to Maude | 2018-12-20 |
| 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 | 4089355124 |
| 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 BASKET |
| Product Code | FGO |
| Date Received | 2018-12-20 |
| Returned To Mfg | 2018-10-24 |
| Model Number | NT4W18115 |
| Lot Number | MK769245 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-12-20 |