MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-06 for 4.5 FR DISPOSABLE ELECTROHYDRAULIC * 27080EA manufactured by Karl Star Endoscopy-america.
[18486090]
Pt admitted for cystourethroscopy (stone removal). Stone was 9-10mm. Attempted a #3 french ehl probe but for some reason it was functioning poorly and the probe would not work. Attempted to introduce a 4. 5 french ehl probe and it did work. It was filing and chipping on the stone when the tip dislodged from the top of the probe, the metal portion, and stayed along the side of the stone. The tip of the stone was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012745 |
| MDR Report Key | 141785 |
| Date Received | 1998-01-06 |
| Date of Report | 1997-12-18 |
| Date of Event | 1997-12-09 |
| Date Added to Maude | 1998-01-08 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4.5 FR DISPOSABLE ELECTROHYDRAULIC |
| Generic Name | LITHOTRIPTOR PROBE |
| Product Code | FGM |
| Date Received | 1998-01-06 |
| Model Number | * |
| Catalog Number | 27080EA |
| Lot Number | 8042 |
| ID Number | * |
| Device Expiration Date | 1994-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 138329 |
| Manufacturer | KARL STAR ENDOSCOPY-AMERICA |
| Manufacturer Address | 10111 W. JEFFERSON BLVD. CULVER CITY CA 902323578 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-01-06 |