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

Device Problems Contamination /Decontamination Problem (2895); Device Contamination With Biological Material (2908)

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

Event Date 11/09/2017

Event Type  Injury  

Manufacturer Narrative

The facility reported performing an endoscopy procedure on a patient with an endoscope which was reprocessed in their dsd-201 automated endoscope reprocessor.During the procedure tissue was found within the endoscope suspected to be from a previous patient.This is potential for patient cross-contamination.The initial reporter checked the operations of their dsd-201 aer and determined all settings and operations were functioning properly.He reported understanding this event is related to improper pre-cleaning of the endoscope.He stated the facility does not have any questions or concerns regarding the medivators aer.There was no report of patient harm and no report of additional medical attention being sought by the patient.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

The facility reported that while performing an endoscopy procedure, tissue was found in the endoscope from the previous patient.This indicates improper pre-cleaning.There is a potential for patient cross-contamination.

• Brand Name: DSD-201
• 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: 7097990
• MDR Text Key: 94194646
• Report Number: 2150060-2017-00051
• 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: user facility
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/07/2017

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2017
• Initial Date FDA Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other