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

Device Problems Use of Incorrect Control/Treatment Settings (1126); Use of Device Problem (1670)

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

Event Date 10/02/2019

Event Type  Injury  

Manufacturer Narrative

The facility reported incorrect parameter settings assigned to endoscopes being reprocessed in their advantage plus automated endoscope reprocessor (aer).There is potential that endoscopes were not adequately high level disinfected prior to patient procedures, thus there is potential for patient cross-contamination.The facility reported noticing their reprocessing cycle was taking less time than normal and called medivators technical support to inquire about their observation.It was discovered that they had the wrong parameter set assigned for olympus pediatric gastroscope model pcf-h190l and other non-specified endoscopes.Medivators technical support assisted the facility with correcting the parameter sets.It was determined that the incorrect parameter sets were used during reprocessing cycles for five days.It is unknown how many endoscopes were reprocessed during this timeframe.According to the advantage plus aer user manual, it is the operator's responsibility to ensure correct parameter sets are assigned to endoscopes being reprocessed in their aer.There have been no reports of patient harm.This complaint will continue being monitored in the medivators complaint handling system.

Event Description

The facility reported incorrect parameter settings assigned to endoscopes being reprocessed in their advantage plus automated endoscope reprocessor (aer).There is potential that endoscopes were not adequately high level disinfected prior to patient procedures, thus there is potential for patient cross-contamination.

• Brand Name: ADVANATGE 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: 9263622
• MDR Text Key: 170479073
• Report Number: 2150060-2019-00068
• 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: K102996
• 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: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2015
• 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