MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-06-04 for KARL STORZ 27069K manufactured by Karl Storz Gmbh & Co. Kg.
[15161993]
The doctor was performing an optical urethrotomy when the tip of the cold knife broke off. Xray confirmed it was positioned next to a catheter in the peno-scrotal junction. Doctor did not want to remove catheter which was difficult to place, so he left the tip of the knife in patient and completed procedure. He waited a week for swelling to go down and then removed the knife tip and the catheter at the same time. Patient condition was reported as good.
Patient Sequence No: 1, Text Type: D, B5
[15452827]
Although the subject instrument was not returned, hospital reported that knife broke on a very hard membraneous mid-prostatic rock hard urethral stricture. Damage most likely due to mechanical overload.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2009-00018 |
| MDR Report Key | 1403474 |
| Report Source | 06 |
| Date Received | 2009-06-04 |
| Date of Report | 2009-06-02 |
| Date of Event | 2009-05-08 |
| Date Facility Aware | 2009-05-13 |
| Report Date | 2009-06-02 |
| Date Reported to FDA | 2009-06-02 |
| Date Reported to Mfgr | 2009-06-02 |
| Date Added to Maude | 2010-03-26 |
| 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 | MITTELSTRASSE 8 |
| Manufacturer City | TUTTLINGEN 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 | 2009-06-04 |
| Model Number | 27069K |
| Catalog Number | 27069K |
| Lot Number | UNK |
| 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 | 2009-06-04 |