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

Model Number DSD-201

Device Problem Facilities Issue (2935)

Patient Problem No Information (3190)

Event Date 08/24/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The case states that a dsd -201 automated endoscope reprocessor did not have the sensors enabled when installed by a third party company.There is potential that high-level disinfection of the endoscopes was not achieved.Potential patient cross-contamination.Ra spoke with (b)(64 fse concerning the disabled sensors in the dsd-201 since being installed in (b)(6) 2014.It was reported that the facility had purchased the machine from a third party.The machine had been moved from a facility in (b)(6) and installed at this facility in (b)(6).The third party did not enable the sensors when installing the machine.This was discovered when the facility called (b)(4) tech service to request a service call.Without temperature or other sensors enabled, it is unknown whether or not the endoscopes being reprocessed were high level disinfected.If a 3rd party has involvement with a (b)(4) product, the warranty and product guarantee are void.(b)(4) can no longer verify parts and services when it is unknown what work or part replacements the third party had performed.During the fse visit, the sensors were enabled and the machine was operational.There have been no reports of patient illness or injury.This incident will be documented in (b)(4) complaint system.

Event Description

The case states that a dsd -201 automated endoscope reprocessor did not have the sensors enabled when installed by a third party vendor.There is potential that high-level disinfection of the endoscopes was not achieved.Potential patient cross-contamination.

• 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: megan dickey ; 14605 28th ave n; minneapolis, MN 55447 ; 7635533327
• MDR Report Key: 5098939
• MDR Text Key: 26589982
• Report Number: 2150060-2015-00027
• 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: 09/18/2015

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: 09/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2006
• 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