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

Device Problem Device Handling Problem (3265)

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

Event Date 10/23/2018

Event Type  Injury  

Manufacturer Narrative

A facility reported white residue on endoscopes after reprocessing in their advantage plus automated endoscope reprocessor (aer).There is potential for patient harm caused by exposure to the residual during endoscopic procedures.Through communication between the facility and medivators clinical education specialist (ces), the cause of the white residue was determined to be from transporting disinfected, wet endoscopes in a bin that was wiped with cavi wipes prior to hanging them to dry.The combination of the water remaining on the exterior of the endoscopes with the disinfectant residual in the bin from the cavi wipes caused the white residue to form on the endoscopes.Medivators ces advised the facility to dry the endoscopes and bin prior to placing the endoscopes in the bin.It is unknown how many endoscopes may have contained the disinfectant residue and used in patient procedures.There have been no reports of patient harm.This complaint will continue being monitored in medivators complaint handling system.

Event Description

A facility reported white residue on endoscopes after reprocessing in their advantage plus automated endoscope reprocessor (aer).There is potential for patient harm caused by exposure to the residual 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: 8086778
• MDR Text Key: 127802811
• Report Number: 2150060-2018-00066
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• 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
• Date Manufacturer Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• 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