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

Device Problems Failure to Disinfect (1175); Improper or Incorrect Procedure or Method (2017)

Patient Problems Exposure to Body Fluids (1745); No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2018

Event Type  Injury  

Manufacturer Narrative

Medivators clinical education specialist (ces) reported while performing in-service training at a facility, she discovered that an operator of their advantage plus automated endoscope re-processors (aers) was placing two endoscopes in each basin of the aer, with only one endoscope connected to the aer hookup.There is potential for patient cross contamination as endoscopes were not properly high level disinfected.Medivators ces was informed by the operator that she has been reprocessing endoscopes as previously described for at least one year.Medivators ces completed the in-service training ensuring all staff were properly trained on proper endoscope reprocessing using the aer and hookups.Medivators has performed numerous in-service trainings at this facility since their first advantage plus aer was installed in 2016.The facility's department management was notified about this event.It is unknown if the facility will contact patients that may have been affected from improperly reprocessed endoscopes.There have been no reports of patient harm.This complaint will continue being monitored in medivators complaint handling system.

Event Description

Medivators clinical education specialist (ces) reported while performing in-service training at a facility, she discovered that an operator of their advantage plus automated endoscope re-processors (aers) was placing two endoscopes in each basin of the aer, with only one endoscope connected to the aer hookup.There is potential for patient cross contamination as endoscopes were not properly high level disinfected.

• 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: 7848832
• MDR Text Key: 119324389
• Report Number: 2150060-2018-00058
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• 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