MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-23 for FLEX-CATCH 4 WIRE NITINOL BASKET NT4F19115 manufactured by Gyrus Acmi, Inc.
[146076862]
The medical device was forward to the manufacturer for evaluation/investigation. Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined. Once the investigation is available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[146076863]
The service center was informed that during stone removal procedure, the user was unable to close or retract the basket after retrieving the stone. The basket was cut and then removed from the patient. The procedure was completed with a similar device. There was no longer stay or additional procedures required for the patient. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00871 |
| MDR Report Key | 8638979 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-23 |
| Date of Report | 2019-07-03 |
| Date of Event | 2019-04-25 |
| Date Mfgr Received | 2019-06-06 |
| Date Added to Maude | 2019-05-23 |
| 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 | FLEX-CATCH 4 WIRE NITINOL BASKET |
| Generic Name | EXTRACTOR, STONE REMOVAL |
| Product Code | FGO |
| Date Received | 2019-05-23 |
| Returned To Mfg | 2019-05-08 |
| Model Number | NT4F19115 |
| Lot Number | 91804370 |
| 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 | 2019-05-23 |