MAUDE Adverse Event Report: MEDIVATORS DSD EDGE; AUTOMATED ENDOSCOPE REPROCESSOR

Device Problems Device Contamination with Chemical or Other Material (2944); Failure to Clean Adequately (4048)

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

Event Date 11/05/2018

Event Type  Injury  

Manufacturer Narrative

The facility reported a tan, granular substance remained in the basin of their dsd edge automated endoscope reprocessor (aer) after reprocessing an endoscope.There is potential for patient exposure to the unknown substance during endoscopic procedures.Communication between the facility's biomed and medivators field service engineers determined that the endoscope may not have been properly manually cleaned before being placed in the aer.After reprocessing the endoscope in the aer and noticing the substance, the facility reprocessed it again in a different aer only to find the same substance remaining in that aer as well.The facility reported after running 10 cycles in the second aer, the substance was gone.Medivators field service engineers evaluated the first aer and the facility's biomed technician performed a full preventative maintenance service after dissassembling the unit and thoroughly flushing and scrubbing the affected components.The unit has been removed from service while the facility continues to run cycles and try to clear out the substance.The facility has since purchased a new advantage plus aer to replace the affected dsd edge.The identification of the substance remains unknown.It is unknown if the endoscope has been used in patient procedures since being reprocessed.There have been no reports of patient harm.This complaint will continue being monitored in medivators complaint handling system.

Event Description

A facility reported a tan, granular substance remained in the basin of their dsd edge automated endoscope reprocessor after reprocessing an endoscope.There is potential for patient exposure to the unknown substance during endoscopic procedures.

• Brand Name: DSD EDGE
• 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: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 8133379
• MDR Text Key: 129341384
• Report Number: 2150060-2018-00072
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: 00677964046674
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/05/2018

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
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2011
• 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
• Patient Outcome(s): Other