MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-07-03 for KARL STORZ 27069K SAME manufactured by Karl Storz Gmbh & Co. Kg.
[1609759]
Allegedly, during an internal urethrotomy and cystoscopy procedure, the tips of the knives broke off in the pt one after another. The first one was retrieved from urethra with some difficulty. After the 2nd knife tip broke, doctor made 2 scrotal incisions to remove the piece without success. He then made an incision in the abdominal area and was able to retrieve the piece. Procedure was aborted at that time and pt moved to icu. Pt suffered renal failure and remained in hospital for treatment.
Patient Sequence No: 1, Text Type: D, B5
[8606018]
Both blades are broken at the base. The broken piece measures a little over 2 cm. We suspect the tips were broken due to excessive mechanical force.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2010-00018 |
| MDR Report Key | 1748180 |
| Report Source | 06 |
| Date Received | 2010-07-03 |
| Date of Report | 2010-07-02 |
| Date of Event | 2010-06-02 |
| Date Facility Aware | 2010-06-03 |
| Report Date | 2010-07-02 |
| Date Reported to FDA | 2010-07-02 |
| Date Reported to Mfgr | 2010-07-02 |
| Device Manufacturer Date | 2009-06-01 |
| Date Added to Maude | 2010-07-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | MITTLESTRASSE 8 |
| Manufacturer City | TUTTLINGEN, POSTFACH 230 78503 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78503 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ |
| Generic Name | COLD KNIFE |
| Product Code | EZO |
| Date Received | 2010-07-03 |
| Model Number | 27069K |
| Catalog Number | SAME |
| Lot Number | FA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH & CO. KG |
| Manufacturer Address | TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2010-07-03 |