MAUDE Adverse Event Report: 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 10/01/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The case states that this facility had a dsd -201 automated endoscope reprocessors.The machine was programmed with only two rinses when rapicide opa instructions require three.The original complaint was regarding opa being left on the scope.It was discovered by medivators technical services that they were only using two rinses and this was adjusted to three.There is potential for patient chemical colitis or irritation from improper rinsing.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

The case states that this facility had a dsd -201 automated endoscope reprocessor.The machine was programmed with only two rinses when rapicide opa instructions require three.There is potential for handler/patient chemical exposure symptoms, irritation, or 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: 5123665
• MDR Text Key: 27337104
• Report Number: 2150060-2015-00029
• 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: user facility
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• 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: 10/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2014
• 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