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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The facility reportedly observed that the metricide opa plus high level disinfectant used in their cer-2 optima automated endoscope reprocessor hld reservoir was cloudy in appearance.The facility confirmed that the opa solution was not expired and the minimum required concentration (mrc) passed for the reprocessing cycle.The initial reporter thought someone may have accidentally topped off the disinfectant reservoir with metrizyme detergent, which they use as part of their pre-cleaning step prior to high-level disinfecting scopes.Therefore, it is unknown if scopes were properly high-level disinfected.It is also unknown if scopes were used on patients, thus potential risk of patient adverse effects from improper hld of scopes.Medivators technical services advised the customer to dump the disinfectant from the reservoir, rinse thoroughly with water, then refill with the opa solution and test the mrc using the solution test strips.The customer followed these directions and confirmed that the mrc passed.To date, there have been no reports of patient harm.Medivators will continue monitoring this complaint in the medivators complaint handling system.
Event or Problem Description
A facility reported noticing the metricide opa plus high level disinfectant used in their cer 2 optima automated endoscope reprocessor hld reservoir was cloudy in appearance.It was suspected that someone accidentally topped off the disinfectant reservoir with metrizyme detergent.There is potential for patient adverse effects such as cross contamination if scopes are not properly high level disinfected.

• Brand Name: CER-2 OPTIMA
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS, INC.; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 6934997
• Report Number: 2150060-2017-00044
• Device Sequence Number: 13594785
• Product Code: NVE
• UDI-Device Identifier: 00677964052491
• UDI-Public: 00677964052491
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K871712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Remedial Action: Notification,Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 10/10/2017

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
• Operator of Device: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other