MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-08-10 for ELITE & USA COLD KNIFE, STRAIGHT BLADE, 3/PKG K-SB manufactured by Gyrus Acmi, Inc..
[1704220]
During a direct visual internal urethrotomy procedure, the blade of the elite cold knife detached and fell into the patient. The blade is still in the patient. X-rays indicate it being located in the cavernosum area, lodged somewhere in the tissue of the penis. The patient was discharged with the knowledge of the blade still inside the body. It may move, or come out during urination. The patient will come back in for a follow-up visit, re-x-ray.
Patient Sequence No: 1, Text Type: D, B5
[8670712]
This device is currently still under investigation and testing at our facility. As a result, a determination cannot be made at this time. When further information becomes available, gyrus acmi will continue the investigation and update the agency accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006159227-2010-00005 |
| MDR Report Key | 1813639 |
| Report Source | 06 |
| Date Received | 2010-08-10 |
| Date of Report | 2010-08-10 |
| Date of Event | 2010-07-07 |
| Date Facility Aware | 2010-07-07 |
| Date Mfgr Received | 2010-07-13 |
| Device Manufacturer Date | 2009-08-01 |
| Date Added to Maude | 2011-09-07 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042739 |
| Manufacturer G1 | GYRUS ACMI, INC. |
| Manufacturer Street | CARRETERA SALTILLO-ZACATECAS KM 4.5 |
| Manufacturer City | LA ANGOSTURA, SALTILLO, COAHUI C.P.250 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | C.P. 2500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELITE & USA COLD KNIFE, STRAIGHT BLADE, 3/PKG |
| Generic Name | COLD KNIFE, STRAIGHT BLADE, 3/PKG |
| Product Code | GDX |
| Date Received | 2010-08-10 |
| Returned To Mfg | 2010-07-21 |
| Model Number | K-SB |
| Catalog Number | K-SB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | CARRETERA SALTILLO-ZACATECAS KM 4.5 LA ANGOSTURA, C.P. MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-10 |