MAUDE Adverse Event Report: MEDIVATORS INC. 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 04/04/2019

Event Type  Injury  

Manufacturer Narrative

A medivators field service engineer (fse) reported a facility had not been using test strips to test the minimum required concentration (mrc) of the high-level disinfectant before each reprocessing cycle in their dsd-201 automated endoscope reprocessor (aer).There is potential that the disinfectant cycle did not reach high-level disinfection, thus there is potential for patient cross-contamination.It is required per the aer user manual to monitor mrc levels.Additionally, the rapicide glutaraldehyde indicator test strip directions for use indicate that the disinfectant should be tested for mrc before each cycle.The number of endoscopes reprocessed without checking mrc is unknown.Medivators fse informed the facility that it is required to test mrc before each disinfectant cycle.There have been no reports of patient adverse events.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

A medivators field service engineer (fse) reported a facility had not been using test strips to test the minimum required concentration (mrc) of the high-level disinfectant before each reprocessing cycle in their dsd-201 automated endoscope reprocessor (aer).There is potential that the disinfectant cycle did not reach high-level disinfection, thus there is potential for patient cross-contamination.

• 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: 8547191
• MDR Text Key: 143035105
• Report Number: 2150060-2019-00032
• 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: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• 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: 04/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2009
• 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