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

Device Problems Use of Device Problem (1670); Facilities Issue (2935)

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

Event Date 10/10/2017

Event Type  Injury  

Manufacturer Narrative

Medivators field service engineer visited the facility and discovered the sensors within the unit had been disabled and the unit was not programmed to the correct settings in accordance with the chemistry's instructions for use.The incorrect programming included: - only one rinse was set for the b-side reservoir.- the high and low reservoir sensors, temperature sensors and the sheath test on the b-side reservoir were all disabled.- the minimum temperature on the b-side was set to 10 degrees celsius.There is potential the endoscopes run under these settings were not properly disinfected or rinsed and therefore there is potential for patient cross-contamination or chemical colitis.The fse determined the settings had been incorrect since (b)(6) 2016.There was no communication or visits with medivators around the time the settings were modified.The facility reported there is a biomed on site who is trained to service the unit.The facility does not have a service agreement with medivators and thus there has been no preventative maintenance performed on the machine by medivators.The fse set the machine back to the correct settings and enabled all tests and sensors.The fse ran test cycles and ensured the unit was operating according to specifications.To date, there have been no reports of patient illness.This complaint will continue to be monitored within medivators complaint handling system.

Event Description

Medivators field service engineer visited the facility and discovered the sensors within the unit had been disabled and the unit was not programmed to the correct settings in accordance with the chemistry's instructions for use.There is potential the endoscopes reprocessed were not properly disinfected or rinsed, thus there is potential for patient cross-contamination or chemical colitis.

• Brand Name: DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR
• 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
• MDR Report Key: 7000659
• MDR Text Key: 91012848
• Report Number: 2150060-2017-00046
• 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: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/03/2017

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2012
• 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