MAUDE Adverse Event Report: MEDIVATORS CER-2; AUTOMATED ENDOSCOPE REPROCESSOR

Device Problem Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Information (3190)

Event Date 04/06/2017

Event Type  Injury  

Manufacturer Narrative

The facility reported they had been using their automated endoscope reprocessor without water filters.This could potentially lead to the introduction of microorganisms and particles to the endoscope during reprocessing and recontamination during rinsing.Therefore, there is potential for patient infection.Medivators tech service advised the facility to install the appropriate filtration system.The facility has since ordered filters assemblies, filters, and hoses.Medivators tech service followed up with the facility to advise them on use and maintenance of filters in their aer.To date, there have been no reports of patient illness.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

The facility reported using cer automated endoscope reprocessor without appropriate water filtration systems.This is a potential for patient harm.

• Brand Name: CER-2
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: sadie martin ; 14605 28th ave n; minneapolis, MN 55447
• MDR Report Key: 6542790
• MDR Text Key: 74355762
• Report Number: 2150060-2017-00024
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K871712
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• 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: 04/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2000
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other