MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-16 for LITHOTRITE * 27076 A manufactured by Karl Storz Endoscopy-america Inc.
[74699]
Lithotrite caught in the cystoscope- m. D. Unable to remove lithotrite from cystoscope sheath. It appeared lithotrite malfunctioned causing the jaws not to open and getting stuck in cystoscope sheath.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012346 |
| MDR Report Key | 127954 |
| Date Received | 1997-10-16 |
| Date of Event | 1997-10-09 |
| Date Added to Maude | 1997-10-27 |
| 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 | LITHOTRITE |
| Generic Name | MECHANICAL LITHOTRITE |
| Product Code | FGK |
| Date Received | 1997-10-16 |
| Model Number | * |
| Catalog Number | 27076 A |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 125202 |
| Manufacturer | KARL STORZ ENDOSCOPY-AMERICA INC |
| Manufacturer Address | 91 CARPENTER HILL RD CHARLTON MA 015073578 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-10-16 |