MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-11 for URETHROSCOPE SHEATH 27040XB manufactured by Karl Storz Endoscopy-america, Inc..
[72364512]
Patient Sequence No: 1, Text Type: N, H10
[72364513]
Patient was here for holmium laser enucleation of the prostate (holep) and the ceramic tip of the holep scope came off in the patient's bladder. The tip was retrieved and removed. The holep scope was removed from the field and a new one was brought in to the or and used to finish case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6479731 |
| MDR Report Key | 6479731 |
| Date Received | 2017-04-11 |
| Date of Report | 2017-03-31 |
| Date of Event | 2016-09-14 |
| Report Date | 2017-03-31 |
| Date Reported to FDA | 2017-03-31 |
| Date Reported to Mfgr | 2017-03-31 |
| Date Added to Maude | 2017-04-11 |
| 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 | 3 |
| Brand Name | URETHROSCOPE SHEATH |
| Generic Name | CYSTOURETHROSCOPE |
| Product Code | FBO |
| Date Received | 2017-04-11 |
| Returned To Mfg | 2017-02-22 |
| Model Number | 27040XB |
| Lot Number | YW 02 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Manufacturer Address | 15 WELLS STREET SOUTHBRIDGE MA 01550 US 01550 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-11 |