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

Device Problems Flushing Problem (1252); Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/14/2019

Event Type  Injury  

Manufacturer Narrative

During a service visit, a medivators field service engineer (fse) reported a facility had the incorrect water line disinfection (wld) cycle setting for their dsd-201 automated endoscope reprocessor (aer).There is a potential contamination risk from not performing the waterline disinfection for the required amount of time.The wld cycle was set to run for thirty minutes, instead of the required one hour, per the rapicide high level disinfectant instructions for use (ifu).The medivators fse informed the facility of the requirement to run the wld cycle for at least one hour per the rapicide ifu.The fse re-programmed the aer to run the wld cycle for one hour per specifications and showed the facility how to perform a wld with the correct settings.This aer was previously serviced by an unknown third-party company.Therefore, no information was provided to medivators regarding how long the wld cycle time was set incorrectly.There are no reported patient adverse events.This complaint will be monitored in the medivators complaint handling system.

Event Description

During a service visit, a medivators field service engineer (fse) reported a facility had the incorrect water line disinfection (wld) cycle setting for their dsd-201 automated endoscope reprocessor (aer).There is a potential contamination risk from not performing the waterline disinfection for the required amount of time.

• Brand Name: DSD-201
• 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: 8332264
• MDR Text Key: 135923635
• Report Number: 2150060-2019-00014
• 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
• Type of Report: Initial
• Report Date: 02/11/2019

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: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 02/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2011
• 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