MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-10-13 for ELITE & USA COLD KNIFE, STRIAGHT BLADE, 3/PKG K-SB manufactured by Gyrus Acmi, Inc..
[1242863]
During a surgical procedure, the distal end of the elite cold knife detached and fell into the pt's body. The piece was retrieved with no pt harm. Another like device was used to complete the procedure with no further incidents.
Patient Sequence No: 1, Text Type: D, B5
[8363789]
At the time of this report, the device has not yet been returned for evaluation. As a result, a determination cannot be made at this time. If further info becomes available, gyrus acmi will continue the investigation and update the agency accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006159227-2009-00006 |
| MDR Report Key | 1517028 |
| Report Source | 07 |
| Date Received | 2009-10-13 |
| Date of Report | 2009-10-13 |
| Date of Event | 2009-06-06 |
| Date Facility Aware | 2009-09-15 |
| Date Mfgr Received | 2009-09-15 |
| Date Added to Maude | 2010-08-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE RD |
| 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 | SALTILLO, COAHUILA 25000 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 25000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELITE & USA COLD KNIFE, STRIAGHT BLADE, 3/PKG |
| Generic Name | COLD KNIFE, STRAIGHT BLADE, 3/PKG |
| Product Code | GDX |
| Date Received | 2009-10-13 |
| Model Number | K-SB |
| Catalog Number | K-SB |
| 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 | GYRUS ACMI, INC. |
| Manufacturer Address | CARRETERA SALTILLO-ZACATECAS KM 4.5 LA ANGOSTURA, C.P. MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-10-13 |