MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-22 for GUIDE, SHEATH, PROBE manufactured by Olympus America, Inc..
[92760103]
Patient Sequence No: 1, Text Type: N, H10
[92760104]
While setting up the guide sheath kit (which is an olympus product) to use with the radial ebus probe, the stopper became broken, which caused damage to the radial probe. The procedure had to be cancelled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7052807 |
| MDR Report Key | 7052807 |
| Date Received | 2017-11-22 |
| Date of Report | 2017-11-03 |
| Date of Event | 2017-10-16 |
| Report Date | 2017-11-03 |
| Date Reported to FDA | 2017-11-03 |
| Date Reported to Mfgr | 2017-11-03 |
| Date Added to Maude | 2017-11-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Generic Name | GUIDE, SHEATH, PROBE |
| Product Code | KTI |
| Date Received | 2017-11-22 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS AMERICA, INC. |
| Manufacturer Address | 3500 CORPORATE PKWY. CENTER VALLEY PA 18034 US 18034 |
| Generic Name | GUIDE, SHEATH, PROBE |
| Product Code | FZX |
| Date Received | 2017-11-22 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS AMERICA, INC. |
| Manufacturer Address | 3500 CORPORATE PKWY. CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-22 |