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

Device Problems Fluid/Blood Leak (1250); Electrical Shorting (2926)

Patient Problems Headache (1880); Nausea (1970); Vomiting (2144); Sore Throat (2396); Chemical Exposure (2570)

Event Date 12/31/2018

Event Type  Injury  

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 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
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 8287449
• MDR Text Key: 134604880
• Report Number: 2150060-2019-00006
• 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: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Manufacturer Received: 12/31/2018
• Initial Date FDA Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2011
• 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