MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-03-09 for USA ELITE SYSTEM USA SERIES COLD KNIFE, STRAIGHT BLADE 99-0527 * manufactured by Acmi Corporation.
[450015]
During a urological procedure, the working element blade (acmi cold knife, straight blade) broke off in the patient's urethra during the procedure. The physician retrieved the blade with no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 691573 |
| MDR Report Key | 691573 |
| Date Received | 2006-03-09 |
| Date of Report | 2006-03-09 |
| Date of Event | 2006-01-18 |
| Report Date | 2006-03-09 |
| Date Reported to FDA | 2006-03-09 |
| Date Added to Maude | 2006-03-27 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | USA ELITE SYSTEM USA SERIES COLD KNIFE, STRAIGHT BLADE |
| Generic Name | BLADE, URETHROTOME |
| Product Code | EZO |
| Date Received | 2006-03-09 |
| Returned To Mfg | 2006-03-09 |
| Model Number | 99-0527 |
| Catalog Number | * |
| Lot Number | 1-0001 REV D 0902 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 3 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 680710 |
| Manufacturer | ACMI CORPORATION |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-03-09 |