MAUDE Adverse Event Report: MEDIVATORS MEDIVATORS CER-1; AUTOMATED ENDOSCOPE REPROCESSOR

Model Number CER-1

Device Problem Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 09/11/2014

Event Type  No Answer Provided  

Event Description

The case states that this facility is using incorrect hookups/ connectors in their medivators cer-1 automated endoscope reprocessor.Potential cross contamination risk.

Manufacturer Narrative

The case states that this facility is using incorrect hookups/ connectors in their medivators cer-1 automated endoscope reprocessor.Potential cross contamination risk.Medivators clinical specialist reported these findings after a visit to this facility.He reported that there were adapters missing to fit specific scope brands.In the cer-1 automated endoscope reprocessor, the forward water jet channel was not hooked up while reprocessing the scopes.Please reference the attached facility product observation form - johnson memorial.To date, there is no reported cases of patient injury or illness.This complaint will continue to be monitored within medivators complaint system.

• Brand Name: MEDIVATORS CER-1
• 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: 4133475
• MDR Text Key: 4793965
• Report Number: 2150060-2014-00039
• 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: 10/01/2014

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: CER-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/16/2014
• Initial Date FDA Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2009
• 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