MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-26 for CYSTO GRASPER manufactured by Gyrus Acmi.
[90430467]
While this pt was having his bladder stones removed under cystoscopic visualization, the meter cysto grasper jaw broke inside his bladder. Dates of use: (b)(6) 2017. Diagnosis or reason for use: removing bladder calculi from inside the bladder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072948 |
| MDR Report Key | 6979153 |
| Date Received | 2017-10-26 |
| Date of Report | 2017-10-24 |
| Date of Event | 2017-10-19 |
| Date Added to Maude | 2017-10-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CYSTO GRASPER |
| Generic Name | CYSTO GRASPER JAW |
| Product Code | GEN |
| Date Received | 2017-10-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI |
| Manufacturer Address | SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-26 |