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

Device Problems Improper or Incorrect Procedure or Method (2017); Contamination /Decontamination Problem (2895); Facilities Issue (2935)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2017

Event Type  Injury  

Manufacturer Narrative

Medivators field service engineer was at the facility to service their (b)(4) automated endoscope reprocessor.The facility did not have test strips and reported they have not been using test strips for years.Test strips are required to test the concentration of the high level disinfectant after an endoscope reprocessing cycle is complete.Test strips must be used in accordance with the aer and high level disinfectant instructions for use.There is potential the minimum concentration of high level disinfectant was not reached during the reprocessing cycles, thus there is potential endoscopes were not high level disinfected and potential for patient cross-contamination.Medivators fse confirmed the aer is operating according to specification.There have not been any reports of patient illness.The facility reported they would begin using test strips after every aer cycle.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

Medivators field service engineer was at the facility to service their (b)(4) automated endoscope reprocessor.The operator of the unit reported to the fse the facility has not been using test strips to test the concentration for the high level disinfectant within the aer for years.There is potential the endoscope reprocessing cycles did not reach the minimum concentration of high level disinfection, and thus there is potential for patient cross-contamination with endoscopes that were not properly disinfected.

• 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: sadie martin ; 14605 28th ave n; minneapolis, MN 55447 ; 7632487189
• MDR Report Key: 7182901
• MDR Text Key: 96993066
• Report Number: 2150060-2018-00004
• Device Sequence Number: 1
• Product Code: FEB
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2014
• 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