MAUDE Adverse Event Report: MEDIVATORS INC. DSD EDGE; HIGH LEVEL DISINFECTANT

Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	11/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The facility reported a leak of rapicide pa high level disinfectant from their dsd edge automated endoscope reprocessor causing two employees to be sent to the emergency room due to exposure symptoms.Medivators field service engineer (fse) was dispatched to the facility and inspected the aer.The fse found that a manifold connector was not working properly and replaced the part.Test cycles were performed, and it was confirmed the unit was running according to specification.Medivators regulatory followed up with the facility and they confirmed one of the employees was wearing a mask at the time of the incident.One of the employees has asthma and was treated for symptoms in the er.They were both provided a doctor's note to be excused from work for three days.There have been no reports of further incidents.The two employees current condition are reported to be fine.This will continue being monitored in the medivators complaint handling system.
Event or Problem Description
The facility reported a leak of rapicide pa high level disinfectant from their dsd edge automated endoscope reprocessor causing two employees to be sent to the emergency room due to exposure symptoms.

• Brand Name: DSD EDGE
• Common Device Name: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS INC.; 14605 287th ave n; plymouth MN 55447
• MDR Report Key: 9490209
• Report Number: 2150060-2019-00073
• Device Sequence Number: 1215274
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: 00677964046674
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K092387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other