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

Model Number 1-2-510.003

Device Problem Fumes or Vapors (2529)

Patient Problem Chemical Exposure (2570)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

The user facility reported an internal leak of rapicide pa high level disinfectant (hld) in the advantage plus automated endoscope repocessor (aer) machine caused ten employees to experience exposure symptoms and were sent for evaluation.A medivators field service engineer (fse) was dispatched to the facility and determined a coupling connector attached to the chemistry overflow tubing had broken, causing an internal leak of hld in the aer.The fse repaired the coupling and performed multiple test cycles to confirm the aer was operating according to specification and was returned to use.No additional medical attention was sought by any of the employees.Medivators will continue to monitor for similar events to ensure the product continues to perform as expected.

Event Description

The user facility reported an internal leak of rapicide pa high level disinfectant (hld) in the advantage plus automated endoscope repocessor (aer) machine caused ten employees to experience exposure symptoms and were sent for evaluation.

• Brand Name: ADVANTAGE PLUS
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; plymouth, mn
• Manufacturer (Section G): MEDIVATORS INC.; 14605 28th ave n; plymouth, mn
• Manufacturer Contact: lauren johnson ; 9800 59th ave n; plymouth, mn
• MDR Report Key: 10387985
• MDR Text Key: 202530431
• Report Number: 2150060-2020-00015
• 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: Repair
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1-2-510.003
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2015
• 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