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

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2017

Event Type  Injury  

Manufacturer Narrative

The facility reported their dsd-201 automated endoscope reprocessor was programmed with the incorrect number and contact time of rinses for the high level disinfectant being used.Metricide high level disinfectant requires 3 rinses at 1 minute each and the facility reprocessed endoscopes with the program set to run 2 rinses at 30 seconds each.Medivators technical service representative instructed the facility over the phone how to set the machine back to the correct program.Per the dsd-201 user manual, users are instructed to verify the program settings are appropriate for the disinfectant being used prior to reprocessing endoscopes.It is unknown if improperly rinsed scopes were used in patient procedures.There is potential for patient chemical colitis or irritation from inadequate rinsing.Medivators regulatory affairs attempted to contact the facility with no success.There have been no reports of patient harm.This complaint will continue being monitored in medivators complaint handling system.

Event Description

A facility reported their dsd-201 automated endoscope reprocessor was programmed with the incorrect number of rinses required for use with the high level disinfectant being used.Inadequate rinsing of endoscopes could potentially cause patient chemical colitis.

• 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; minneapolis MN 55447
• Manufacturer Contact: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 7200127
• MDR Text Key: 97541310
• Report Number: 2150060-2018-00006
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2018

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2010
• 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: METRICIDE HLD
• Patient Outcome(s): Other