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

Device Problems Blocked Connection (2888); Connection Problem (2900)

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

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

The facility reported a medline cleaning brush broke off inside their olympus ercp flexible endoscope.The scope was reprocessed in a medivators advantage plus automated endoscope reprocessor (aer) and used on a subsequent patient.A medline double ended cleaning brush that was used to manually clean the olympus ercp flexible endoscope and broke off inside the channel.The endoscope was then reprocessed in the aer and used in a subsequent procedure.It was reported that during the procedure the physician attempted to call for suction and noticed a blockage in the suction channel.The brush fell out onto the floor during the procedure.The facility did further investigation and determined two brushes could fit in the same channel at the same time which is why the broken brush went undetected and the fluid/air flow through the channel was not impacted to alarm the aer.Medivators field service engineer(fse) visited the facility and tested the aer.He ran blockage detection verification test by clamping the suction channel and the machine alarmed as intended and the cycle operated according to specification.The medline double ended cleaning brush was recalled in june of 2018 under recall number z-3210-2018.There is potential risk of brush detachment during cleaning.If brush detachment is not identified, there is the potential for the brush to be left within the scope.It is unknown if the facility was aware of this recall.No adverse events were reported because of this issue.This will continue to be monitored in the medivators complaint handling system.

Event Description

The facility reported a medline cleaning brush broke off inside their olympus ercp flexible endoscope.The scope was reprocessed in a medivators advantage plus automated endoscope reprocessor (aer) and used on a subsequent patient.

• Brand Name: ADVANTAGE PLUS
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer Contact: lauren johnson ; 14605 28th ave n; plymouth, MN 55447
• MDR Report Key: 8201075
• MDR Text Key: 131584620
• Report Number: 2150060-2018-00080
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2014
• 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