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

Model Number DSD-201

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem Chemical Exposure (2570)

Event Date 09/08/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The case states that the facility's dsd-201 automated endoscope reprocessor (aer) was set to the wrong program.The aer was set to have only 2 rinses when rapicide opa/28 instructions require 3 and thus was not adequately rinsing endoscopes during reprocessing cycles.The facility called medivators technical service to see if their aer was set up properly and it was discovered that the machine was set to the wrong program.Medivators technical service assisted the facility in changing the aer to the correct program.It is unknown how long the facility was reprocessing scopes with the wrong number of rinses.Improper rinsing could leave residual disinfectant on the scope, therefore potential handler and patient chemical exposure symptoms such as irritation or chemical colitis.To date, there have been no reports of illness or injury.This complaint will continue to be monitored within the medivators complaint handling system.

Event Description

The case states that the facility's dsd-201 automated endoscope reprocessor (aer) was set to the wrong program.The aer was set to have only 2 rinses when rapicide opa/28 instructions require 3 and thus was not adequately rinsing endoscopes during reprocessing cycles.Improper rinsing could leave residual disinfectant on the scope, therefore potential handler and patient chemical exposure symptoms such as irritation or chemical colitis.

• Brand Name: MEDIVATORS 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: kristin bergeson ; 14605 28th ave n; minneapolis, MN 55447
• MDR Report Key: 5127981
• MDR Text Key: 27482766
• Report Number: 2150060-2015-00030
• 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: Other
• Remedial Action: Modification/Adjustment
• Report Date: 10/05/2015

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: No Information
• Device Model Number: DSD-201
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2008
• 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
• Treatment: RAPICIDE OPA/28