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

Device Problems Use of Incorrect Control/Treatment Settings (1126); Off-Label Use (1494)

Patient Problems Chemical Exposure (2570); No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that a facility was reprocessing endoscopes in their dsd-201 automated endoscope reprocessor (aer) with the incorrect amount of rinses per the high-level disinfectant labeling and aer instructions-for-use.The facility was using metricide opa hld which requires 3 rinses but their aer was set up with 2 rinses.There is potential that endoscopes may have contained hld residual after reprocessing which could cause chemical colitis or adverse reactions to patients.While onsite to perform a preventative maintenance service, medivators field service engineer (fse) discovered that the facility originally had their aer set up for using rapicide opa/28 hld which requires 2 rinses.The facility switched to using metricide opa that morning but did not change the aer settings to add the third rinse per the hld labeling.Medivators fse informed the facility of the required 3 rinses for use with metricide opa and changed the aer settings to have the correct amount of rinses.It is estimated 20-30 endoscopes were reprocessed that day before medivators fse arrived onsite and updated the aer parameter settings.As stated in the dsd-201 user manual, operators are required to ensure the aer is set up with the correct parameter settings in accordance with the hld manufacturer's labeling and instructions.There were no reports of patient harm.This complaint will continue being monitored in medivators complaint handling system.

Event Description

It was reported that a facility was reprocessing endoscopes in their dsd-201 automated endoscope reprocessor (aer) with the incorrect amount of rinses per the high-level disinfectant labeling and aer instructions-for-use.The facility was using metricide opa hld which requires 3 rinses but their aer was set up with 2 rinses.There is potential that endoscopes may have contained hld residual after reprocessing which could cause chemical colitis or adverse reactions to patients.

• Brand Name: DSD-201
• 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: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 8063992
• MDR Text Key: 126924580
• Report Number: 2150060-2018-00071
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• 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: 10/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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