MAUDE Adverse Event Report: MEDIVATORS INC. DSD EDGE; 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	03/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During a service visit, a medivators field service engineer (fse) reported a facility had not been performing water line disinfection (wld) cycles for their four dsd edge automated endoscope reprocessors (aer).There is potential risk of contamination of the endoscopes reprocessed in the aers from not performing wld in accordance with the aer user manual.Medivators fse discovered the facility had not performed wld since the four aers were installed on (b)(6) 2018.The number of endoscopes reprocessed during this time is unknown.Medivators fse retrained the facility on the importance of completing a wld as instructed in the aer user manual.There have been no reports of patient adverse events.This complaint will continue to be monitored in medivators complaint handling system.
Event or Problem Description
During a service visit, a medivators field service engineer (fse) reported a facility had not been performing water line disinfection (wld) cycles for their four dsd edge automated endoscope reprocessors (aer).There is potential risk of contamination of the endoscopes reprocessed in the aers from not performing wld in accordance with the aer user manual.

• 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: 8471059
• Report Number: 2150060-2019-00026
• Device Sequence Number: 13846920
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: 00677964046674
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K092387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2019

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: 03/14/2019
• Initial Report FDA Received Date: 04/01/2019
• 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