MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-11-22 for KARL STORZ 27068/27069 NA manufactured by Karl Storz Gmbh & Co. Kg.
[3060086]
Allegedly, the tip of the cold knife broke off in patient during a cystoscopy and urethrotomy procedure. The doctor was unable to remove broken piece. On (b)(6) 2010, the doctor conducted surgery to remove retained piece, but was unable to do so. Piece remains in patient. This occurred at: (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[10382885]
The legal summons did not identify the part number of the instrument involved. It could be series (b)(4) cold knives.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2012-00039 |
| MDR Report Key | 2896991 |
| Report Source | 00 |
| Date Received | 2012-11-22 |
| Date of Report | 2012-11-21 |
| Date of Event | 2010-10-28 |
| Date Facility Aware | 2012-10-22 |
| Report Date | 2012-11-20 |
| Date Reported to FDA | 2012-11-20 |
| Date Reported to Mfgr | 2012-11-20 |
| Date Added to Maude | 2013-01-07 |
| 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 POSTFACH 230 |
| 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 | 2012-11-22 |
| Model Number | 27068/27069 |
| Catalog Number | NA |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2012-11-22 |