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

Device Problem Facilities Issue (2935)

Patient Problems Chemical Exposure (2570); No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

The facility reported a grey fluid dripping from their endoscopes when they are hung to dry after reprocessing in their advantage plus automated endoscope reprocessor (aer).The facility did not take the suspect endoscope(s) out of service when the grey fluid was noticed, thus there is potential for patient harm due to exposure to the unknown substance.The facility was unable to identify which endoscope was the source of the grey fluid.Medivators field service engineer visited the facility and confirmed their advantage plus aers are operating according to specification and do not contain a grey substance that would contribute to the grey fluid.The endoscope manufacturer uses a dry grey lubricant inside the endoscope and it is suspected this could be the source of the substance.It was reported the endoscope manufacturer sales representative was going to be visiting the facility.Medivators ra followed up with the facility regarding the visit and current status of the issue but was unable to get in contact with the facility.There have been no reports of patient harm.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

The facility reported a grey fluid dripping from their endoscopes when they are hung to dry after reprocessing in their advantage plus automated endoscope reprocessor (aer).The facility did not take the suspect endoscope(s) out of service when the grey fluid was noticed, thus there is potential for patient harm due to exposure to the unknown substance.

• 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: sadie martin ; 14605 28th ave n; minneapolis, MN 55447
• MDR Report Key: 7379571
• MDR Text Key: 103777958
• Report Number: 2150060-2018-00021
• 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: K082988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other