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

Device Problem Failure to Clean Adequately (4048)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 01/04/2019

Event Type  Injury  

Manufacturer Narrative

It was reported by the facility that a piece of tissue was found in the olympus egd endoscope biopsy channel during a procedure.The endoscope was reprocessed in their advantage plus automated endoscope re-processor (aer).The tissue was potentially from the previous patient, thus the potential for cross-contamination.The origin of the tissue remains unknown.In ra follow up the facility reported they bedside clean their endoscopes after procedures by wiping them down and flushing with water.Then the endoscope gets brought to sterile processing where it's placed in a tub of enzymatic detergent before manual cleaning.During the procedure, the physician placed forceps down the biopsy channel and as he pushed it through he noticed a piece of tissue on the end of the forceps.The physician immediately removed the tissue through the biopsy channel and then they removed the endoscope from the patient.The physician used another endoscope to finish the procedure.No patient harm was reported.Medivators field service engineer(fse) investigate the aer.He found no errors on the machine.The fse tested the machine and it ran within specification.This will continue to be monitored in the medivators complaint system.

Event Description

It was reported by the facility that a piece of tissue was found in the olympus egd endoscope biopsy channel during a procedure.The endoscope was reprocessed in their advantage plus automated endoscope re-processor (aer).The tissue was potentially from the previous patient, thus the potential for cross-contamination.

• 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: 8265357
• MDR Text Key: 133711132
• Report Number: 2150060-2019-00008
• 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: user facility
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2016
• 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