MAUDE Adverse Event Report: MEDIVATORS SCOPE BUDDY; ENDOSCOPE FLUSHING AID

Model Number	EFA-US-G
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The facility was not properly manually cleaning in accordance with the scope buddy ifu.The facility did have the appropriate connectors for the scope buddy.Their flushing procedure was to draw out 100 ml of solution from the container, then remove the uptake tube and place it in the rinse water to again draw out another 100 ml.The facility reported an olympus rep.Taught them this method.Medivators clinical specialist communicated with facility staff leader that the 100 ml was per channel, not per scope.The facility immediately implemented the change.It is unknown how many endoscopes were flushed using the incorrect processes.No serious injuries reported.To date, there have been no reports of patient illness or injury.This complaint will continue to be monitored in the medivators complaint handling system.
Event or Problem Description
The case states the facility was not properly manually cleaning endoscope prior to placement in aer, potential for patient cross-contamination.

• Brand Name: SCOPE BUDDY
• Common Device Name: ENDOSCOPE FLUSHING AID
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 6353711
• Report Number: 2150060-2017-00008
• Device Sequence Number: 18940815
• Product Code: FEB
• UDI-Device Identifier: 00677964063640
• UDI-Public: 00677964063640
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K914524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 02/23/2017

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
• Operator of Device: No Information
• Device Model Number: EFA-US-G
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2017
• Initial Report FDA Received Date: 02/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1