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

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 07/09/2018

Event Type  Injury  

Manufacturer Narrative

A facility reported an unknown yellow residue in the basin and drain screens of their advantage plus automated endoscope reprocessors (aers).There is potential for patient exposure to the unknown residue during endoscopic procedures.Medivators field service engineer visited the facility to evaluate and clean the units to remove the yellow residue.The units were thoroughly inspected and samples of the yellow residue were gathered for analysis by medivators r&d.Results from the analysis of the samples identified a silicone-based substance.The source of the silicone-based substance remains unknown, however medivators technical specialist and fse confirmed this substance could not be introduced by any component from the aer.The facility continues to investigate the source of this substance.The aers have been used for about a year and a half but reported the residue was noticed for the first time recently.It is unknown if changes in the processes at the facility have occurred, causing the residue.The facility reported they have not observed the residue on any endoscopes.It is unknown how many endoscopes have been reprocessed.The facility reported they are keeping the drain screens clean and are monitoring their units closely.There have been no reports of patient harm.Medivators has followed up with the facility but has not received any further information.This complaint will continue being monitored in medivators complaint handling system.

Event Description

A facility reported an unknown yellow residue in the basin and drain screens of their advantage plus automated endoscope reprocessors (aers).There is potential for patient exposure to the unknown residue during endoscopic procedures.

• Brand Name: ADVANTAGE PLUS
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 7765051
• MDR Text Key: 116529309
• Report Number: 2150060-2018-00051
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/08/2018

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
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• 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