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

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The facility reported blue fluid, the same color as their cidex opa high level disinfectant solution (hld), on a pentax pediatric endoscope prior to a patient procedure.Medivators field service engineer visited the facility to evaluate their dsd-201 automated endoscope reprocessor to determine the cause of the hld residual.During his visit, the fse determined that the medical technician was not using the counter weight attached to the distal tip of the pediatric scope containing the hld residual.Without the counter weight attached, the scope would spray hld solution around the basin during reprocessing, leaving hld residual in the aer and on the scope.Improper cleaning of the basin between cycles and not following the scope manufacturer's instructions for proper scope reprocessing could allow hld residuals to be introduced to patients and potentially cause chemical colitis.Medivators fse confirmed the aer is operating according to specification.He also informed the customer the importance of using the counter weight on the scope during reprocessing.There have been no reports of patient harm.Medivators will continue monitoring this complaint in medivators complaint handling system.
Event or Problem Description
The facility reported blue fluid, the same color as their high level disinfectant, found on an endoscope after reprocessing in their dsd-201 automated endoscope reprocessor.Medivators field service engineer found that the facility was not using the counter weight on the distal tip of their pediatric scope, causing the scope to spray hld solution around the aer basin during reprocessing.Improper cleaning of the basin between cycles and not following the scope manufacturer's instructions for proper scope reprocessing could allow hld residuals to be introduced to patients and potentially cause chemical colitis.

• Brand Name: DSD-201
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 7274711
• Report Number: 2150060-2018-00008
• Device Sequence Number: 1014744
• Product Code: FEB
• UDI-Device Identifier: 00677964033858
• UDI-Public: 00677964033858
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K914145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 02/15/2018

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
• Operator of Device: Medical Technologist
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other