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

Device Problem Use of Incorrect Control/Treatment Settings (1126)

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

Event Date 08/16/2019

Event Type  Injury  

Manufacturer Narrative

The facility reported incorrect parameter sets assigned to two types of endoscopes being reprocessed in their advantage plus automated endoscope repossessor (aer).There is potential that endoscopes were not properly high-level disinfected, thus there is potential for patient cross contamination.It is unknown how long the facility was using the incorrect parameter sets and how many endoscopes were potentially not adequately reprocessed.Upon identifying the incorrect parameter sets assigned for the two types of endoscopes, the facility immediately corrected them with assistance from mediators clinical education specialist (ces) over the phone.According to the advantage plus aer user manual, it is the operator's responsibility to ensure correct parameter sets are assigned to endoscopes being reprocessed in their aer.The facility has received multiple in-service trainings by mediators ces and related documentation regarding proper use of their aer including assigning correct parameter sets for endoscopes.There have been no reports of patient harm.This complaint will continue being monitored in mediators complaint handling system.

Event Description

The facility reported incorrect parameter sets assigned to two types of endoscopes being reprocessed in their advantage plus automated endoscope repossessor (aer).There is potential that endoscopes were not properly high-level disinfected, thus there is potential for patient cross contamination.

• 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: 9042484
• MDR Text Key: 162259735
• Report Number: 2150060-2019-00062
• 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
• Type of Report: Initial
• Report Date: 09/13/2019

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?: Yes
• Initial Date Manufacturer Received: 08/16/2019
• Initial Date FDA Received: 09/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• 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