MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-10-27 for KARL STORZ 27068K manufactured by Karl Storz Gmbh & Co..
[160987]
During a cystoscopic procedure, a urethrotome blade broke off. Doctor was pretty sure the broken tip was left inside of the pt. However, the piece did not show up on either x-ray or fluoroscopy. Extensive search was conducted in the or and they could find no signs of the tip. Procedure was 6 hours in duration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020550-1999-00018 |
| MDR Report Key | 247584 |
| Date Received | 1999-10-27 |
| Date of Report | 1999-10-26 |
| Date of Event | 1999-10-14 |
| Date Facility Aware | 1999-10-18 |
| Report Date | 1999-10-26 |
| Date Reported to FDA | 1999-10-26 |
| Date Reported to Mfgr | 1999-11-03 |
| Date Added to Maude | 1999-11-03 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | COLD KNIFE |
| Product Code | EZO |
| Date Received | 1999-10-27 |
| Model Number | 27068K |
| Catalog Number | 27068K |
| Lot Number | HZ |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 14 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 239857 |
| Manufacturer | KARL STORZ GMBH & CO. |
| Manufacturer Address | MITTELSTRASSE 8 POSTFACH 230 TUTTLINGEN GM 78503 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-10-27 |