MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-25 for OLYMPUS / GYRUS ACMI 61224BX manufactured by Gyrus Acmi.
[99033718]
During a ureteroscopy, the tip of a uropass ureteral access sheath 12/14 fr x 24cm broke off. The broken piece was removed by cystoscopy. The procedure was completed but the case was prolonged approx 10 - 15 mins. The tip appeared to be brittle and dry.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7237924 |
| MDR Report Key | 7237924 |
| Date Received | 2018-01-25 |
| Date of Report | 2017-10-23 |
| Date of Event | 2017-08-28 |
| Date Added to Maude | 2018-02-02 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | OLYMPUS / GYRUS ACMI |
| Generic Name | UROPASS URETERAL ACCESS SHEATH |
| Product Code | KNY |
| Date Received | 2018-01-25 |
| Returned To Mfg | 2017-11-02 |
| Catalog Number | 61224BX |
| Lot Number | 09F1600053 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBNOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-25 |