MAUDE Adverse Event Report: MEDIVATORS INC. ADVANTAGE PLUS; AUTOMATED ENDOSCOPE REPROCESSOR

Device Problem No Apparent Adverse Event (3189)

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

Event Date 03/26/2019

Event Type  Injury  

Manufacturer Narrative

During a service visit for an advantage plus automated endoscope re-processor (aer), a medivators field service engineer (fse) reported the right basin spray head of the aer was not spinning during a reprocessing cycle.There is potential that endoscopes reprocessed in the right basin of the aer were not adequately high-level disinfected and, therefore, potential for patient cross-contamination.Medivators fse replaced the right basin spray head and returned the unit to service.The aer user manual instructs users to verify that the spray head is spinning during each reprocessing cycle.If not, the exterior parts of endoscopes that are not fully submerged in the basin during reprocessing are potentially not adequately high-level disinfected.The internal channels of the endoscope are not affected and would have been properly high-level disinfected.The portion of the endoscope in direct contact with the patient is placed toward the bottom of the aer basin during reprocessing and would be fully submerged during the cycle and, therefore, receive adequate high-level disinfection.At this time, the types and number of endoscopes reprocessed while the right basin spray head was not spinning is unknown.There have been no reports of patient harm.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

During a service visit for an advantage plus automated endoscope re-processor (aer), a medivators field service engineer (fse) reported the right basin spray head of the aer was not spinning during a reprocessing cycle.There is potential that endoscopes reprocessed in the right basin of the aer were not adequately high-level disinfected and, therefore, potential for patient cross-contamination.

• Brand Name: ADVANTAGE PLUS
• 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: hannah shrader ; 14605 28th ave n; minneapolis, MN 55447 ; 7635596863
• MDR Report Key: 8547022
• MDR Text Key: 143036876
• Report Number: 2150060-2019-00033
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: 00677964044755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• 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