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

Device Problem Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Date 11/25/2019

Event Type  Injury  

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 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
• Type of Device: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS INC.; 14605 287th ave n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS INC.; 14605 28th ave n; plymouth MN 55447
• Manufacturer Contact: lauren johnson ; 14605 28th ave n; plymouth, MN 55447
• MDR Report Key: 9490209
• MDR Text Key: 172710129
• Report Number: 2150060-2019-00073
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: 00677964046674
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other