MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-09 for VERISCAN VER-LT 01 manufactured by Medivators Inc..
[116914287]
Noted post-cystoscopy that the integrity of flexible cystoscopy sheath had been jeopardized with a visible crack in the outer sheath. Scope praised multiple automated leak tests with the veriscan and after further evaluation failed a manual leak test. Scope and veriscan (automated leak tester) were both removed from service immediately. Veriscan was sent to company - medivators for evaluation and didn't find any items to contribute to the errors.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079031 |
| MDR Report Key | 7772433 |
| Date Received | 2018-08-09 |
| Date of Report | 2018-08-08 |
| Date of Event | 2018-06-14 |
| Date Added to Maude | 2018-08-10 |
| 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 | VERISCAN |
| Generic Name | BULB, INFLATION FOR ENDOSCOPE |
| Product Code | FCY |
| Date Received | 2018-08-09 |
| Returned To Mfg | 2018-06-15 |
| Model Number | VER-LT 01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS INC. |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-09 |