MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-10-24 for COLD KNIFE, STRAIGHT BLADE, 3/PKG K-SB manufactured by Gyrus Acmi, Inc..
[5065728]
It was reported that in the middle of a urethrotomy direct visual internal procedure the tip of the device broke off inside the patient's urethra. The physician used a grasper to retrieve the broken tip and the procedure was completed. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[12458240]
The device referenced in this report has not been returned to olympus for evaluation. If additional information or if the device is received at a later time, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2014-00475 |
| MDR Report Key | 4226430 |
| Report Source | 05,06 |
| Date Received | 2014-10-24 |
| Date of Report | 2014-10-07 |
| Date of Event | 2014-08-25 |
| Date Mfgr Received | 2014-10-07 |
| Date Added to Maude | 2014-11-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI SCHAMBACH |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLD KNIFE, STRAIGHT BLADE, 3/PKG |
| Generic Name | SCALPEL |
| Product Code | GDX |
| Date Received | 2014-10-24 |
| Model Number | K-SB |
| Catalog Number | K-SB |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | 136 TURNPIKE RD. SOUTHBOROUGH MA 01772210 US 01772 2104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-10-24 |