MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for URETERO-RENO-FIBERSCOPE FLEX-X? FLEX-X2S manufactured by Karl Storz Endoscopy-america, Inc..
[184082452]
The patient was undergoing bilateral ureteroscopies due to ureteral stones. Flexible ureteroscope placed into the left ureter. Laser was used to bust up the stones. As procedure continued, physician tried to pull the scope back. He met resistance and felt like the scope was stuck. Retraction techniques utilized/attempted. Rigid cystoscope utilized. Upon inspection, the outside lining of the flexible scope was very loose and was bunching.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9852990 |
| MDR Report Key | 9852990 |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-24 |
| Report Date | 2020-03-04 |
| Date Reported to FDA | 2020-03-04 |
| Date Reported to Mfgr | 2020-03-19 |
| Date Added to Maude | 2020-03-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | URETERO-RENO-FIBERSCOPE FLEX-X? |
| Generic Name | URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID |
| Product Code | FGB |
| Date Received | 2020-03-19 |
| Model Number | FLEX-X2S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Manufacturer Address | 2151 E. GRAND AVENUE EL SEGUNDO CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |