MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-10-02 for VIENNA RING APPLICATOR manufactured by Varian Mediacl System.
[17445485]
This problem involves varian medical's brachytherapy vienna ring applicator and the mick needle bender. The vienna ring is used to treat cervical cancer using hdr brachytherapy. The vienna ring applicator has a series of holes around the rim of the build up cap to place additional treatment needles. Varian supplies these needles unbent and you must use a mick needle bender to bend needles to the appropriate angle to match the angle of the vienna ring applicator. This issue is: the vienna ring angles are determined from the vertical and the mick needle bender's angles are determined from the horizontal. The vienna rings and needle bender have three available angles 30, 45, and 60 degrees. Due to the orientation issue, the 60 degrees vienna ring must use the 30 degrees needles from the mick needle bender and the 30 degrees vienna ring must use the 60 degrees needles from the mick needle bender. This is very confusing and will result in incorrectly bent needles used with the vienna ring applicator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5032146 |
| MDR Report Key | 3390539 |
| Date Received | 2013-10-02 |
| Date of Report | 2013-10-01 |
| Date of Event | 2013-10-01 |
| Date Added to Maude | 2013-10-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIENNA RING APPLICATOR |
| Generic Name | VIENNA RING APPLICATOR |
| Product Code | JAQ |
| Date Received | 2013-10-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VARIAN MEDIACL SYSTEM |
| Brand Name | MICKE NEEDLE ENDER |
| Generic Name | NEEDLE BENDER |
| Product Code | IWJ |
| Date Received | 2013-10-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MICKE RADIO- NUCLEAR INSTRUMENTS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-10-02 |