MAUDE Adverse Event Report: MEDIVATORS MEDIVATORS DSD EDGE; AUTOMATED ENDOSCOPE REPROCESSOR

Model Number DSD EDGE

Device Problem Device Disinfection Or Sterilization Issue (2909)

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

Event Date 07/29/2014

Event Type  No Answer Provided  

Event Description

The case states that this facility admits to pouring cidex opa high level disinfectant into the rapicide pa bottle to be used in their medivators dsd edge automated endoscope reprocessor.Cidex opa and rapicide pa are not interchangable in the dsd edge machine, therefore endoscopes reprocessed were not properly disinfected.There is potential for cross contamination.

Manufacturer Narrative

The case states that this facility admits to pouring cidex opa high level disinfectant into the rapicide pa bottle to be used in their medivators dsd edge automated endoscope reprocessor.Cidex opa and rapicide pa are not interchangable in the dsd edge machine, therefore endoscopes reprocessed were not properly disinfected.There is potential for cross contamination.Two medivators sales representatives visited this facility and confirmed this facility was using cidex opa in their dsd edge machine.The facility made claims to having their own data that showed the opa was acceptable to use in the dsd edge aer.The sales representative reported that the materials manager stated the practicing physicians did their own research.The product specifications of cidex opa in corelation to the dsd edge reprocessing cycle requirements are completely different.The facilities practices do not follow the dfu for the medivators dsd-edge machine, nor does it meet the compliance standards approved by the fda.The continuation of these practices has concern for inadequate disinfection of endoscopes being used on patients and potential for cross contamination.Medivators training, technical service, sales, and regulatory personnel have all contacted this facility to advise on the importance of following proper reprocessing guidelines.To date, there are no confirmed reports of patient injury or illness as a result of this incident.This complaint will continue to be maintained within medivators complaint system.

• Brand Name: MEDIVATORS DSD EDGE
• 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: megan dickey ; 14605 28th ave n; minneapolis, MN 55447 ; 7635533327
• MDR Report Key: 4027765
• MDR Text Key: 19092399
• Report Number: 2150060-2014-00032
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/20/2014

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
• Device Operator: Other
• Device Model Number: DSD EDGE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/29/2014
• Initial Date FDA Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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