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

Device Problems Failure to Disinfect (1175); Improper or Incorrect Procedure or Method (2017); Residue After Decontamination (2325)

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

Event Date 04/05/2019

Event Type  Injury  

Manufacturer Narrative

Medivators sales representative reported observing the facility's technician incorrectly reprocessing endoscopes in their cer-2 optima automated endoscope reprocessor (aer).It was reported that the required aer hookup connectors were not being used to reprocess the endoscopes.In addition, bioburden was observed on the distal end of the endoscope, inside of the hookup tubing and on all suction valves.There is potential for patient contamination from using improperly reprocessed endoscopes during patient procedures.While observing the incorrect processes, medivators sales representative immediately informed the technician who cancelled the cycle and made the necessary corrections.The facility's physician was also informed of the observations.As stated in medivators cer-2 optima aer user manual, users must inspect the endoscope and hookup combination to verify proper connection and flow.It is also the responsibility of the facility to ensure all reprocessing processes are in place and that staff are properly trained.Following the site visit, it was reported that the facility received an additional in-service training by medivators clinical education specialist for all their medivators products.The facility reported they updated their protocols and staff were required to watch all training videos and review all ifus/user manuals.It was reported that the facility also switched to using medivators single-use disposable valves, disposable tubing and pull-thru cleaning devices.There were no reports of patient harm.This complaint will continue being monitored in the medivators complaint handling system.

Event Description

Medivators sales representative reported observing the facility's technician incorrectly reprocessing endoscopes in their cer-2 optima automated endoscope reprocessor (aer).It was reported that the required aer hookup connectors were not being used to reprocess the endoscopes.In addition, bioburden was observed on the distal end of the endoscope, inside of the hookup tubing and on all suction valves.There is potential for patient contamination from using improperly reprocessed endoscopes during patient procedures.

• 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: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 8575470
• MDR Text Key: 143889862
• Report Number: 2150060-2019-00036
• Device Sequence Number: 1
• Product Code: NVE
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• 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