MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-17 for DSD-201 manufactured by Medivators.
[142336143]
Medivators field service engineer (fse) reported while onsite at the facility for a service visit that the facility's dsd-201 automated endoscope reprocessor (aer), endoscopes and hookups were stained with a green residue. There is potential for patient harm from exposure to the green residue and potential that endoscopes were not adequately high level disinfected. Medivators fse reported that the green substance is from a combination of the detergent (orthozime) mixing with the high-level disinfectant (cidex opa) used in their aer. It was determined that the facility incorrectly programmed their aer for detergent use which caused the detergent to be mixed with the high-level disinfectant in the basin during reprocessing cycles. The facility was informed by medivators fse of the potential impact to patient safety due to the coating of the green substance in the aer and on endoscopes and the potential that endoscopes are not being adequately high level disinfected. The facility received in-service training on the dsd-201 aer in 2007 and 2014 provided by medivators clinical education specialist. The dsd-201 user manual also instructs users to verify proper programming of the aer's cycle settings. It is unknown if the facility continues to use the affected aer. There have been no reports of patient harm. This complaint will continue being monitored in medivators complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[142336144]
Medivators field service engineer (fse) reported while onsite at the facility for a service visit that the facility's dsd-201 automated endoscope reprocessor (aer), endoscopes and hookups were stained with a green residue. There is potential for patient harm from exposure to the green residue and potential that endoscopes were not adequately high level disinfected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2019-00030 |
| MDR Report Key | 8524712 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-17 |
| Date of Report | 2019-04-17 |
| Date of Event | 2019-03-19 |
| Date Mfgr Received | 2019-03-19 |
| Device Manufacturer Date | 2007-04-26 |
| Date Added to Maude | 2019-04-17 |
| 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 | ALEX NELSON |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635094799 |
| Manufacturer G1 | MEDIVATORS |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DSD-201 |
| Generic Name | AUTOMATED ENDOSCOPE REPROCESSOR |
| Product Code | FEB |
| Date Received | 2019-04-17 |
| 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 MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-17 |