MAUDE Adverse Event Report: MEDIVATORS ADVANTAGE PLUS; AUTOMATED ENDOSCOPE REPROCESSOR

Device Problems Fluid/Blood Leak (1250); Fumes or Vapors (2529); Electrical Shorting (2926)

Patient Problem Chemical Exposure (2570)

Event Date 11/20/2018

Event Type  Injury  

Manufacturer Narrative

The facility reported an operator of their advantage plus automated endoscope re-processor (aer) experienced a respiratory ailment from exposure to rapicide pa high level disinfectant fumes when the lid of the aer opened during a waterline disinfection (wld) cycle.Medivators field service engineer (fse) was dispatched to evaluate the aer at the facility.After troubleshooting the affected aer, the fse noticed fluid residue on the circuit board.Medivators fse also noticed a cracked coupling within the aer which may have caused a leak during the wld cycle.The leaking component may have caused an electrical short in the circuit board causing the lid to open during the wld cycle.Medivators fse repaired the aer and confirmed it is now operating within specification.Medivators regulatory followed up with the facility after the reported incident and the sterile processing supervisor at the facility confirmed the operator was exposed to fumes from the hld use-solution in the basin of the aer when the lid opened.When performing a wld cycle, the peracetic acid (paa) concentration of the hld use-solution is approximately 0.2% which presents a low risk of adverse effects if exposed.When the lid opened during the wld cycle due to fluid contacting the circuit board as described above, the cycle stopped and presented an error message, as designed.Medivators has not received information from the facility regarding the current status of the affected operator or if medical attention was sought.Medivators has performed a risk assessment of this failure mode and has determined that the risk is acceptable and appropriate risk control measures are in place.This failure mode is a multi-fault scenario and is the only reported occurrence in the entire marketing history of this device.Medivators remains in close contact with the facility.This complaint will continue being monitored in medivators complaint handling system.

Event Description

The facility reported an operator of their advantage plus automated endoscope re-processor (aer) experienced a respiratory ailment from exposure to rapicide pa high level disinfectant fumes when the lid of the aer opened during a waterline disinfection cycle.

• Brand Name: ADVANTAGE PLUS
• 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: 8180192
• MDR Text Key: 130885337
• Report Number: 2150060-2018-00075
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: 00677964044755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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