MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-07 for DSD EDGE manufactured by Medivators.
[144323069]
It was reported by the facility a technician experienced inhalation exposure symptoms from rapicide pa high level disinfectant (hld) after removing an endoscope during the disinfection cycle from their dsd edge automated endoscope reprocessor(aer). The facility reported while running a cystoscope in the aer the distal tip was pointing upwards. As a result, hld was spraying out of the lid gasket area. The technician stopped the cycle to reposition the endoscope. While opening the lid, they inhaled fumes. Then, the technician sought medical attention for respiratory concerns. It was reported they are doing fine now. The user manual for dsd edge states that the distal end of the endoscope must not point upwards toward the floating lid and must be completely submerged when the basin is filled. The user manual also cautions users about opening the lid during the disinfection process as exposure to vapor can cause sensitization. The technician did not follow instructions. It is unknown if they were wearing the appropriate ppe while handling. This complaint will continue to be monitored in the medivators complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[144323070]
It was reported by the facility a technician experienced inhalation exposure symptoms from rapicide pa high level disinfectant (hld) after removing an endoscope during the disinfection cycle from their dsd edge automated endoscope reprocessor(aer).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2019-00038 |
| MDR Report Key | 8588122 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-07 |
| Date of Report | 2019-05-07 |
| Date of Event | 2019-04-15 |
| Date Mfgr Received | 2019-04-15 |
| Device Manufacturer Date | 2019-01-29 |
| Date Added to Maude | 2019-05-07 |
| 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 | LAUREN JOHNSON |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer G1 | MEDIVATORS |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DSD EDGE |
| Generic Name | AUTOMATED ENDOSCOPE REPROCESSOR |
| Product Code | FEB |
| Date Received | 2019-05-07 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS |
| Manufacturer Address | 14605 28TH AVE N PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-07 |