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

Device Problems Loss of Data (2903); Data Problem (3196)

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

Event Date 10/12/2017

Event Type  Injury  

Manufacturer Narrative

The facility reported they are certain they reprocessed an endoscope using their advantage plus automated endoscope reprocessor, however no cycle report receipt was printed and there was no evidence of the cycle data in the (b)(4)'s database.Medivators technical service representative remotely accessed the (b)(4)'s database and confirmed that the scope and cycle in question were not present in the database.Medivators technical specialist stated that cycle data is written to the database as soon as a cycle is started and there should be some record in the (b)(4) database regardless if the cycle completed or not.Without evidence of the cycle data, it cannot be confirmed that the scope was high level disinfected using the (b)(4), thus potential for patient cross contamination.The facility reported they follow appropriate pre-cleaning processes using medivators scope buddy flushing aid prior to reprocessing.To date, there have been no reports of patient illness or adverse effects.This complaint will continue being monitored in medivators complaint handling system.

Event Description

The facility reported missing cycle data of a reprocessed endoscope in their advantage plus automated endoscope reprocessor, therefore it can not be confirmed that the scope was high level disinfected.There is potential for patient cross contamination.

• 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.; minnapolis MN 55447
• Manufacturer Contact: alex nelson ; 14605 28th ave n.; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 7018251
• MDR Text Key: 91764683
• Report Number: 2150060-2017-00048
• Device Sequence Number: 1
• Product Code: FEB
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2017

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: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/12/2017
• Initial Date FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2010
• 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