MAUDE Adverse Event Report: MEDIVATORS DSD EDGE; AUTOMATED ENDOSCOPE REPROCESSOR

Medical Device Problem Codes	Fluid/Blood Leak (1250); Electrical Shorting (2926)
Health Effect - Clinical Codes	Headache (1880); Nausea (1970); Vomiting (2144); Sore Throat (2396); Chemical Exposure (2570)
Date of Event	12/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A facility reported an internal component of their dsd edge automated endoscope reprocessor (aer) arced and burned, causing a thermally damaged hose inside the machine to leak diluted high-level disinfectant (hld) solution.The facility reported 6 staff members sought medical attention from inhalation symptoms of nausea, vomiting, headaches, sore throat and light-headedness due to this incident.After the reported spill of diluted hld solution occurred in the reprocessing room, the building was evacuated and the spilled hld solution was cleaned up.Medivators regulatory followed up with the facility for further information regarding the staff who reported seeking medical attention.They reported that all affected staff had improved and no further medical attention was sought.The facility also confirmed no patients were affected or harmed.The affected aer was removed from service and returned to medivators for further investigation.Medivators r&d engineers and technical specialists fully inspected the unit and determined the cause of the arcing which was due to fluid ingression inside the gfi box.The unit was not plugged into a gfi wall outlet.It was also determined that this facility uses their aers twice as much as other facilities.Medivators remains in close contact with the facility and continues to investigate the root cause.This complaint will continue being monitored within medivators complaint handling system.
Event or Problem Description
A facility reported an internal component of their dsd edge automated endoscope reprocessor (aer) arced and burned, causing a thermally damaged hose inside the machine to leak diluted high-level disinfectant (hld) solution.The facility reported 6 staff members sought medical attention from inhalation symptoms of nausea, vomiting, headaches, sore throat and light-headedness due to this incident.

• Brand Name: DSD EDGE
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 8287449
• Report Number: 2150060-2019-00006
• Device Sequence Number: 2418602
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: 00677964046674
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K092387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2019

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: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2018
• Initial Report FDA Received Date: 01/29/2019
• 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