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

Device Problem Off-Label Use (1494)

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

Event Date 05/20/2019

Event Type  Injury  

Manufacturer Narrative

Medivators sales representative reported a facility using prolystica enzymatic instrument detergent in their advantage plus automated endoscope reprocessor (aer).Prolystica detergent is not validated for use with the advantage plus aer.Per the aer ifu, only intercept detergent is validated for use in the cleaning cycle of the aer, therefore there is potential that the endoscopes cleaned with prolystica detergent were not adequately reprocessed.It is unknown how long the facility has been using prolystica with their advantage plus aer.It was reported that the facility otherwise follows appropriate reprocessing processes.Medivators field service representative instructed the facility to discontinue use of prolystica detergent with the advantage plus aer.There have been no reports of patient harm.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

Medivators sales representative reported a facility using prolystica enzymatic instrument detergent in their advantage plus automated endoscope reprocessor (aer).Prolystica detergent is not validated for use with the advantage plus aer.Per the aer ifu, only intercept detergent is validated for use in the cleaning cycle of the aer, therefore there is potential that the endoscopes cleaned with prolystica detergent were not adequately reprocessed.

• 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: hannah shrader ; 14605 28th ave n; minneapolis, MN 55447 ; 7635596863
• MDR Report Key: 8684983
• MDR Text Key: 147572241
• Report Number: 2150060-2019-00048
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2011
• 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