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

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 03/11/2019

Event Type  Injury  

Manufacturer Narrative

Medivators field service engineer (fse) reported that while on site at a facility performing maintenance, he observed the facility using modified hookups and the incorrect parameter sets for cidex opa in the dsd 201 automated endoscope reprocessor (aer).There is potential that endoscopes were not properly high-level disinfected, thus there is potential for cross-contamination.The facility was using cidex opa high level disinfectant (hld) at fifteen degrees for a twelve minute contact time which is not in accordance with the labeling.Cidex opa hld instructions for use state use at a minimum temperature of twenty degrees for five minutes.The fse adjusted the temperature of the aer and informed the facility to order the correct hookup.The facility does not have a medivators service contract, therefore it is the facilities responsibility to perform proper maintenance on their machine.Per the medivators dsd-201 user manual, users are required to verify correct parameter settings are appropriate for the type of hld utilized.No information was provided to medivators regarding how many cycles or endoscopes were reprocessed.It cannot be determined if the endoscopes were properly high-level disinfected during this timeframe.It is unknown if the facility has ordered a new hookup.There have been no reports of adverse events or patient harm.This will continue to be monitored in the medivators complaint handling system.

Event Description

Medivators field service engineer reported that while on site at a facility performing maintenance, he observed the facility using modified hookups and the incorrect parameter sets for cidex opa in the dsd 201 automated endoscope reprocessor (aer).There is potential that endoscopes were not properly high-level disinfected, thus there is potential for cross-contamination.

• 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.; plymouth MN 55447
• Manufacturer Contact: lauren johnson ; 14605 28th ave n; minneapolis, MN 55447
• MDR Report Key: 8466920
• MDR Text Key: 140435527
• Report Number: 2150060-2019-00025
• 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: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2003
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other