MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-03-29 for SYSTEM 83 PLUS 83 PLUS 2 83+2 manufactured by Custom Ultrasonics.
[2576961]
It was reported by (b)(6) hospital that a tech was using an "f6" "wash-only" function on the system 83 plus, bypassing the terminal "f7" "wash- disinfect cycle. It was also determined that the "f6" safety cover was removed by operator, using the device off-label, and not following the mfr's specifications and label warning. The technician had been doing this for approx a month. Since upper and lower gi endoscopes were improperly processed in the system 83. There is low risk of disease transmission. A risk assessment has been provided to the hospital and will accompany the filing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523209-2012-00001 |
| MDR Report Key | 2516489 |
| Report Source | 05,06,07 |
| Date Received | 2012-03-29 |
| Date of Report | 2012-03-23 |
| Date of Event | 2012-03-12 |
| Date Mfgr Received | 2012-03-12 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2012-04-05 |
| 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 | 0 |
| Manufacturer Street | 144 RAILROAD DR. |
| Manufacturer City | IVYLAND PA 18974 |
| Manufacturer Country | US |
| Manufacturer Postal | 18974 |
| Manufacturer Phone | 2153641477 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSTEM 83 PLUS |
| Generic Name | ULTRASONIC WASHER HIGH LEVEL DISINFECTOR |
| Product Code | NVE |
| Date Received | 2012-03-29 |
| Model Number | 83 PLUS 2 |
| Catalog Number | 83+2 |
| Lot Number | 2586, 2586-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CUSTOM ULTRASONICS |
| Manufacturer Address | IVYLAND PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-03-29 |