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

Model Number 78400-877

Device Problem Accessory Incompatible (1004)

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

Event Date 04/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6) clinical specialist visited the facility on (b)(6) 2017.They reported observing discrepancies in the facility's reprocessing processes.These discrepancies include the following: the use of resert xl high level disinfectant in the cer-2 optima aer.The absence in daily maintenance to check operations/functionality of the aer in accordance with the device ifu.Cleaning and reprocessing endoscopes with the olympus suction switchover lever attached to endoscope.It was reported that the facility was using resert xl high level disinfectant (hld) in their cer-2 optima for the reprocessing of endoscopes.The cer optima cannot be programmed to meet the labeling use requirements of resert xl hld, as well as it is not chemically compatible with the cer-2 optima aer.(b)(6) clinical specialist advised the facility to stop using resert xl, and recommended use of high level disinfectant compatible with the cer-2 optima aer.The facility requested that their machine be programmed to rapicide opa hld.The clinical specialist also noticed the facility had not been performing daily water flow verification on their hookups prior to use in the cer optima aer as instructed in the ifu, daily quality assurance procedure.It was reported that during the clinical specialist visit that there were hookups in the facilities inventory that did not pass the daily qa procedure, thus there is potential of incomplete disinfection of their endoscopes.Additionally, the clinical specialist observed the facility was storing and reprocessing endoscopes in the cer optima with the olympus suction switchover lever still attached.It was reported upon visual inspection of the lever when removed from the endoscope; there was buildup of dried debris.The olympus endoscope reprocessing manual states, the lever should be detached for brushing and manual cleaning stages as well as reprocessing.The facility was not following the scope manufacturer's ifu.This is potential for patient cross-contamination.This facility does not have a service agreement with (b)(6) on their cer optima.A service agreement would provide the facility necessary preventative maintenance for the machine as well as annual training.There have been no reports of patient illness or injury; however, these observations are potential causes of patient harm.This complaint will continue to be monitored in the (b)(6) complaint handling system.(b)(4).

Event Description

(b)(6) clinical specialist visited and reported the facility is not using their endoscope reprocessing accessories in accordance to the cer optima and endoscope manufacturer's instructions for use.

• Brand Name: CER-2 OPTIMA
• 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: 6568075
• MDR Text Key: 75209064
• Report Number: 2150060-2017-00026
• 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: company representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 78400-877
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• 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
• Treatment: OLYMPUS ENDOSCOPES; RESERT XL HIGH LEVEL DISINFECTANT
• Patient Outcome(s): Other