MAUDE Adverse Event Report: MEDIVATORS ADVANTAGE PLUS AUTOMATED ENDOSCOPE REPROCESSOR

Model Number 1-2-510.003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 04/13/2021

Event Type  Injury  

Manufacturer Narrative

The user facility reported that a patient developed colitis following a colonoscopy procedure using an endoscope that had been reprocessed in their advantage plus automated endoscope reprocessor (aer).Following reprocessing in the aer, the endoscope was placed in an endodry cabinet until use in the patient procedure.The user facility reported the colitis was believed to be due to the rapicide pa high-level disinfectant used in the aer.The reprocessing cycle parameter sets used with the endoscope were reviewed and confirmed to be correct.The reprocessing cycle printout was reviewed by the user facility and confirmed that the cycle was completed without error and the rinse cycle was completed appropriately.Medivators performed a batch record review on the lot of high-level disinfectant in the machine at the time the endoscope was reprocessed and no anomalies were identified.Additional retain testing confirmed the high-level disinfectant met specification.Medivators will continue to monitor for similar events to ensure that the product continues to perform as expected.

Event Description

The user facility reported that a patient developed colitis following a colonoscopy procedure using an endoscope that had been reprocessed in their advantage plus automated endoscope reprocessor (aer).Following reprocessing in the aer, the endoscope was placed in an endodry cabinet until use in the patient procedure.The user facility reported the colitis was believed to be due to the rapicide pa high-level disinfectant used in the aer.

• Brand Name: ADVANTAGE PLUS AUTOMATED ENDOSCOPE REPROCESSOR
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer Contact: mitchell cole ; 14605 28th ave n; plymouth, MN 55447 ; 7638984338
• MDR Report Key: 11803070
• MDR Text Key: 249944066
• Report Number: 2150060-2021-00007
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/10/2021

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: Health Professional
• Device Model Number: 1-2-510.003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 05/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2020
• 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