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

Model Number DSD-201

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems Exposure to Body Fluids (1745); Chemical Exposure (2570)

Event Date 08/04/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Medivators field service engineer was onsite to repair a dsd-201 automated endoscope reprocessor's air compressor.They observed the facility remove an endoscope from the machine prior to cycle completion and then passed off for patient use.Thus, there is potential cross contamination and potential for patient chemical colitis.It was reported that their machine was modified for use with contraindicated, 3rd party filtration system and air/water/hld filters.To date, there have been no reports of patient illness or injury.This complaint will continue to be monitored within the medivators complaint system.

Event Description

Medivators field service engineer was onsite to repair a dsd-201 automated endoscope reprocessor's air compressor.They observed the facility remove an endoscope from the machine prior to cycle completion and then passed off for patient use.Thus, there is potential cross contamination and potential for 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: megan dickey ; 14605 28th ave n; minneapolis, MN 55447 ; 7635533327
• MDR Report Key: 5896660
• MDR Text Key: 52769377
• Report Number: 2150060-2016-00036
• 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
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• 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
• Date Manufacturer Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2004
• 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