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

Model Number 78400-877

Device Problems Display Difficult to Read (1181); Contamination /Decontamination Problem (2895)

Patient Problems Exposure to Body Fluids (1745); No Known Impact Or Consequence To Patient (2692)

Event Date 08/24/2017

Event Type  Injury  

Manufacturer Narrative

The facility reported using endoscopes that had failed reprocessing cycles in their cer-2 optima automated endoscope reprocessor and then used in patient procedures.There is potential for patient cross contamination because the endoscope might not have been appropriately high-level disinfected.The user at the facility thought the endoscopes had passed the reprocessing cycle when the printouts read "low hld level," which means the cycle failed per the cer-2 optima instructions for use.Medivators has informed and educated the facility of how the printouts indicated a failed cycle.They were informed that the cer-2 optima requires 5 gallons of chemistry for proper operation and the disinfectant cycle.The facility has scheduled an in-service for additional training with medivators clinical specialist.There have been no reports of patient illness or injury.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

The facility reported using endoscopes that had failed reprocessing cycles in their cer-2 optima automated endoscope reprocessor and then used in patient procedures.There is potential for patient cross contamination because the endoscope might not have been appropriately high-level disinfected.

• Brand Name: CER-2 OPTIMA
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: sadie martin ; 14605 28th ave n; minneapolis, MN 55447
• MDR Report Key: 6883030
• MDR Text Key: 87164192
• Report Number: 2150060-2017-00040
• 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: Notification
• Type of Report: Initial
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2013
• 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