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

Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The facility reported using the incorrect hookup when reprocessing endoscopes in their dsd edge automated endoscope reprocessor (aer).There is potential that endoscopes were not properly high level disinfected, thus there is potential for patient cross-contamination.There were two reported instances of the facility using endoscopes in patient procedures that were reprocessed using the incorrect hookup.Medivators technical services representative informed the facility that high-level disinfection cannot be guaranteed if the incorrect hookup is used.The facility reported they are now using the correct hookup for this endoscope and have retrained their staff.Per the medivators dsd edge user manual, users are required to verify the correct hookup is used for the type of endoscope being reprocessed.There have been no reports of patient harm.This will continue being monitored in medivators complaint handling system.
Event or Problem Description
The facility reported using the incorrect hookup when reprocessing endoscopes in their dsd edge automated endoscope reprocessor (aer).There is potential that endoscopes were not properly high level disinfected, thus there is potential for patient cross-contamination.

• Brand Name: DSD EDGE
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave. n.; minneapolis MN 55447
• MDR Report Key: 9225224
• Report Number: 2150060-2019-00066
• Device Sequence Number: 13491536
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: 00677964046674
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K092387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/23/2019

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: Other
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 10/23/2019
• 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