MAUDE Adverse Event Report: MEDIVATORS DSD-201 AER; AUTOMATED ENDOSCOPE REPROCESSOR

Model Number DSD-201

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 12/23/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The case states that an enzymatic detergent was inadvertently loaded into the disinfectant reservoir on a dsd-201 automated endoscope reprocessor.It is unknown as to whether patient scopes were run using the detergent with no disinfectant, thus potential scopes were not high level disinfected and potentially used in a patient procedure.There is potential for cross contamination between patients.Medivators technical service representative instructed them to rinse tank and flush machine, then fill reservoir appropriately with intended high level disinfectant.There have been no reports of patient illness or injury.This complaint will continue to be monitored in medivators complaint system.

Event Description

The case states that an enzymatic detergent was inadvertently loaded into the disinfectant reservoir on a dsd-201 automated endoscope reprocessor.It is unknown as to whether patient scopes were run, thus potential scopes were not high level disinfected then used in a patient procedure.There is potential for cross contamination between patients.

• Brand Name: DSD-201 AER
• 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; minneapolis MN 55447
• Manufacturer Contact: megan dickey ; 14605 28th ave n; minneapolis, MN 55447 ; 7635533327
• MDR Report Key: 6268686
• MDR Text Key: 65454727
• Report Number: 2150060-2017-00004
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964033858
• UDI-Public: 00677964033858
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DSD-201
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2010
• 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
• Treatment: ENZYMATIC DETERGENT