MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-15 for WIRE TWSITER 05-500 040-400 manufactured by Alto Development Corp..
[59936027]
Patient Sequence No: 1, Text Type: N, H10
[59936028]
During cardiac surgery the surgeon was using the wire twister when a washer fell off of the instrument. The washer was successfully located in the surgical drapes, resulting in no harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6101842 |
| MDR Report Key | 6101842 |
| Date Received | 2016-11-15 |
| Date of Report | 2016-11-09 |
| Date of Event | 2016-11-08 |
| Report Date | 2016-11-09 |
| Date Reported to FDA | 2016-11-09 |
| Date Reported to Mfgr | 2016-11-09 |
| Date Added to Maude | 2016-11-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WIRE TWSITER |
| Generic Name | TWISTER, WIRE |
| Product Code | HXS |
| Date Received | 2016-11-15 |
| Returned To Mfg | 2016-11-09 |
| Model Number | 05-500 |
| Catalog Number | 040-400 |
| ID Number | TUZIK 040-500; 220500; 05-500 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALTO DEVELOPMENT CORP. |
| Manufacturer Address | 5206 ASBURY RD. FARMINGDALE NJ 07727 US 07727 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-15 |