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

Device Problem No Apparent Adverse Event (3189)

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

Event Date 12/20/2019

Event Type  Injury  

Manufacturer Narrative

The facility reported two endoscopes had brown fluid leaking from them after being reprocessed in their advantage plus automated endoscope reprocessor (aer).It was determined that the facility was not performing required manual bedside cleaning steps post procedure, thus there is potential endoscopes have not been reprocessed properly.It was reported that the operating room (or) staff were going to use two olympus endoscopes in a procedure, but it was discovered that both had a brown fluid leaking from the distal tip.The scopes were not used in the procedure.The facility biomed troubleshot the aer with (b)(4) technical services assisting via phone.The machine operated as intended.The biomed also reported the machine had preventative maintenance completed the month prior and there have been no reported issues.The biomed reported they discovered that manual bedside cleaning was not being performed post procedure in accordance with the endoscope reprocessing instructions for use.The or staff have been informed that manual bedside cleaning is required after each endoscope procedure prior to reprocessing.It is unknown how long they have not been performing manual bedside cleaning or how many endoscopes were potentially not reprocessed appropriately.There have been no reported adverse events.This complaint will continue to be monitored in the (b)(4) complaint system.

Event Description

The facility reported two endoscopes had brown fluid leaking from them after being reprocessed in their advantage plus automated endoscope reprocessor (aer).It was determined that the facility was not performing required manual bedside cleaning steps post procedure, thus there is potential endoscopes have not been reprocessed properly.

• 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: 8241912
• MDR Text Key: 132912371
• Report Number: 2150060-2019-00005
• 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 Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 01/11/2019

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
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2015
• 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