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

Device Problems Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

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

Event Date 07/10/2019

Event Type  Injury  

Manufacturer Narrative

A facility reported reprocessing endoscopes in their advantage plus automated endoscope reprocessor (aer) using two rapicide pa high level disinfectant (hld) part a bottles.The aer is intended for use with one bottle of rapicide pa part a and one bottle of rapicide pa part b to produce the required use-solution mixture for endoscope disinfection.There is potential for chemical exposure from using endoscopes in patient procedures that were reprocessed with double the concentration of rapicide pa part a.Medivators regulatory followed up with the facility in which it was reported that they identified all affected endoscopes and reprocessed them correctly.It was reported that one endoscope may have been used in a patient procedure that was reprocessed incorrectly with the two bottles of rapicide pa part a.No patient injury was reported.It was reported that this issue was escalated to the facility's upper management which resulted in retraining staff and putting up signs reminding operators to verify correct usage of both rapicide pa part a and part b in the aer.The advantage plus aer user manual states the requirement to use only with rapicide pa part a and part b.There have been no reports of patient or user harm.This complaint will continue being monitored in medivators complaint handling system.

Event Description

A facility reported reprocessing endoscopes in their advantage plus automated endoscope reprocessor (aer) using two rapicide pa high level disinfectant (hld) part a bottles.The aer is intended for use with one bottle of rapicide pa part a and one bottle of rapicide pa part b to produce the required use-solution mixture for endoscope disinfection.There is potential for chemical exposure from using endoscopes in patient procedures that were reprocessed with double the concentration of rapicide pa part a.

• 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: 8876406
• MDR Text Key: 153869696
• Report Number: 2150060-2019-00059
• Device Sequence Number: 1
• Product Code: FEB
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• 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: 07/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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