MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-07 for KARL STORZ * 27074B manufactured by Karl Storz.
[71580]
Dr was doing cystoscopy, lithopoxy, trans urethral resection of the prostate (turp), using the hendricks optical stone crushing forcep. While crushing stone in bladder the instrument broke with jaws in an open position. The dr was left with no option but to remove the instrument through the urethra; instrument intact; jaws fixed open; no retained pieces.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 109731 |
| MDR Report Key | 109731 |
| Date Received | 1997-07-07 |
| Date of Report | 1997-01-24 |
| Date of Event | 1997-01-23 |
| Date Facility Aware | 1997-01-23 |
| Report Date | 1997-01-24 |
| Date Added to Maude | 1997-08-01 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ |
| Generic Name | LITHOTRITE |
| Product Code | FGK |
| Date Received | 1997-07-07 |
| Model Number | * |
| Catalog Number | 27074B |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1.5 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 107857 |
| Manufacturer | KARL STORZ |
| Manufacturer Address | 10111 W JEFFERSON BLVD CULVER CITY CA 902323578 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-07-07 |