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

Device Problem Inadequate or Insufficient Training (1643)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2019

Event Type  Injury  

Manufacturer Narrative

A facility reported that after a medivators fse repaired the printer for their advantage plus automated endoscope reprocessor, it was recognized that an endoscope was not properly reprocessed and was used during a patient procedure, thus there is potential for patient harm.The facility determined that the endoscope was not properly reprocessed while reviewing the print-outs from previous cycles when the printer was not working.It is the facility's responsibility to review cycle logs after each cycle to ensure endoscopes achieved adequate high level disinfection.Even in the event where the printer is not functioning, the aer monitor clearly displays all the necessary information for each reprocessing cycle.Medivators district manager followed up with the facility about this incident in which they confirmed only one endoscope was impacted.The facility indicated they did not need further in-service training, as offered by medivators.There was no report of patient harm.This complaint will continue being monitored in medivators complaint handling system.

Event Description

A facility reported that after a medivators fse repaired the printer for their advantage plus automated endoscope reprocessor, it was recognized that an endoscope was not properly reprocessed and was used during a patient procedure, thus there is potential for patient harm.

• Brand Name: ADVANTAGE PLUS
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave. n.; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC.; 14605 28th ave. n.; minneapolis MN 55447
• Manufacturer Contact: alex nelson ; 14605 28th ave. n.; minneapolis, MN 55447 ; 6125058332
• MDR Report Key: 8851958
• MDR Text Key: 152976136
• Report Number: 2150060-2019-00056
• 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: K102996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2018
• 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