MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-12-21 for KARL STORZ 27069K NA manufactured by Karl Storz Gmbh & Co. Kg.
[19194893]
Allegedly, at conclusion of a transurethral incision of bladder neck procedure, doctor noted that tip of knife was missing. He located tip, had the pt further anesthetized, and then performed a cystoscopy procedure to remove piece. Both procedures were completed with no impact on pt.
Patient Sequence No: 1, Text Type: D, B5
[19412349]
Hospital is not releasing instrument.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2012-00046 |
| MDR Report Key | 2901397 |
| Report Source | 05,06 |
| Date Received | 2012-12-21 |
| Date of Report | 2012-12-21 |
| Date of Event | 2010-08-23 |
| Date Facility Aware | 2012-11-26 |
| Report Date | 2012-12-21 |
| Date Reported to FDA | 2012-12-21 |
| Date Reported to Mfgr | 2012-12-21 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2013-01-18 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | MITTELSTRASSE 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 | 2012-12-21 |
| Model Number | 27069K |
| Catalog Number | NA |
| Lot Number | IA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2012-12-21 |