MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-02-08 for ULTRA-CATCH NT (2.2 FR X 115 CM) STONE RETRIEVAL DEVICE NT4W22115 manufactured by Gyrus Acmi, Inc.
[138540164]
The referenced device and original packaging was returned to olympus for evaluation. The evaluation confirmed the original (outer) box was severely crushed and opened as its seal was torn off. The (inner) packing tray containing the device inside is also crushed with multiple dents on the edge of the package, likely causing the packaging tray seal label to lift up and become slightly open; therefore, the sterile barrier was breached. The device appeared to be intact, and in new condition. Based on the evaluation, the reported event is likely due to improper handling from excessive force applied during transit or storage. The dhr review for this device was conducted. All records indicate that the device was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.
Patient Sequence No: 1, Text Type: N, H10
[138540165]
Olympus was informed that upon receipt of the device the device packaging was observed to be heavily damaged and the unit was unusable. There was no patient involvement. It was not specified if the sterile packaging of the device had been breached.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00428 |
| MDR Report Key | 8324279 |
| Report Source | USER FACILITY |
| Date Received | 2019-02-08 |
| Date of Report | 2019-02-08 |
| Date of Event | 2018-12-13 |
| Date Mfgr Received | 2019-01-15 |
| Date Added to Maude | 2019-02-08 |
| 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 | 3 |
| Brand Name | ULTRA-CATCH NT (2.2 FR X 115 CM) STONE RETRIEVAL DEVICE |
| Generic Name | STONE RETRIEVAL BASKET |
| Product Code | FGO |
| Date Received | 2019-02-08 |
| Returned To Mfg | 2019-01-08 |
| Model Number | NT4W22115 |
| Lot Number | MK803710 |
| Device Availability | R |
| 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 | 2019-02-08 |