MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2016-02-11 for FLEXITRON HDR manufactured by Nucletron.
[38004564]
The user has used the incorrect adaptor. User error. Investigation ongoing. User error; not device related.
Patient Sequence No: 1, Text Type: N, H10
[38004705]
Patient mistreated with lumencath in combination wtih flexitron. This customer is an old mselectron customer and for mselectron you have to use the adaptor/connector connected to the lumencath when using the x-ray markers. They also used this procedure for flexitron, but for flexitron you should not use the adaptor when using the x-ray marker. The result is a mistreatment of ~4. 5cm.
Patient Sequence No: 1, Text Type: D, B5
[47917438]
The user used a procedure and adaptor from another device they previously used, a microselectron afterloader. The correct procedure was already discussed in the flexitron user manual. The applicable section of the flexitron user manual is re-distributed ((b)(4)) in a product bulletin. The redistributed information emphasizes again the correct workflow.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611894-2016-00001 |
| MDR Report Key | 5430309 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2016-02-11 |
| Date of Report | 2016-06-21 |
| Date of Event | 2015-04-03 |
| Date Mfgr Received | 2016-01-18 |
| Date Added to Maude | 2016-02-11 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | GPMS GPMS |
| Manufacturer Street | ELEKTA LTD LINAC HOUSE, FLEMING WAY, |
| Manufacturer City | CRAWLEY, UK RH109RR |
| Manufacturer Country | UK |
| Manufacturer Postal | RH10 9RR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXITRON |
| Generic Name | SYSTEM, APPLICATOR< RADIONUCLIDE, REMOTE_CONTROLLED |
| Product Code | JAQ |
| Date Received | 2016-02-11 |
| Model Number | HDR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUCLETRON |
| Manufacturer Address | WAARDGELDER 1 VEENENDAAL, 3905TH NL 3905 TH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-11 |