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

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Skin Discoloration (2074); Chemical Exposure (2570)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

The facility reported a reprocessing technician experienced chemical exposure symptoms (chemical burns, skin discoloration) after handling an endoscope and other items reprocessed in their advantage plus automated endoscope reprocessor.The facility's biomedical service technician and medivators field service engineer evaluated the aers and performed test cycles, confirming the units operated within specification.During the fse's visit at the facility, it was noticed that a plastic container of reuseable valves, buttons and several other items was placed in the aer along with the scope for reprocessing.According to medivators advantage plus user manual, endoscope accessories disinfected in the aer must be placed in the mesh bag medivators provides with the aer.Therefore, using the foreign plastic container is an unapproved, off-label use of the machine.There is also potential that these accessories were not properly high level disinfected since this container is not validated for use with the advantage plus aer.Medivators regulatory affairs followed up with the facility's biomed.And he stated the chemical exposure was due to a handling issue during the reprocessing process and they have since changed their process accordingly.The exposed personnel was reported to have received medical attention at their hospital and is doing fine.This complaint will continue being monitored in medivators complaint handling system.

Event Description

The facility reported an endoscope reprocessing technician experienced chemical exposure symptoms after handling an endoscope and other items that were reprocessed in their advantage plus automated endoscope reprocessor.The cause of the chemical exposure was determined to be due to improper reprocessing and handling processes by the technician.The exposed personnel received medical attention at their facility and is reported to be doing fine.

• 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: 7293237
• MDR Text Key: 100843141
• Report Number: 2150060-2018-00013
• 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: Hospital Service Technician
• Type of Report: Initial
• Report Date: 02/23/2018

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: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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