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

Model Number CER-1

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 11/11/2014

Event Type  No Answer Provided  

Event Description

The case states that this facility had 4 confirmed cases of chemical colitis after performing endoscopy procedures.

Manufacturer Narrative

The case states that the facility had at least 4 confirmed cases of chemical colitis.This facility reprocesses their endoscopes using a medivators cer-1 automated endoscope reprocessor and medivators rapicide gluteraldehyde.During the annual preventative maintenance visit for their cer-1 machine, medivators field service engineer did a full process/ in-depth review of the facilities routine for endoscope reprocessing.It was reported they were using modified hook-ups for connecting the endoscope to the cer-1 automated endoscope reprocessor.It was also reported that this facility was not reprocessing the maj-855 olympus reuseable tubing using the appropriate steps validated for high level disinfection.These practices have potential for cross contamination.All other observations reported by the field service engineer confirmed that the medivators machine was operating to specifications and there was no other identified issues with their processes using the rapicide high level disinfectant.To date, there is no patient illness or injury events.This complaint will continue to be monitored within medivators complaint system.

• Brand Name: 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: 4310080
• MDR Text Key: 19970935
• Report Number: 2150060-2014-00046
• 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,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/08/2014

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
• Initial Date Manufacturer Received: 11/11/2014
• Initial Date FDA Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2006
• 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
• Treatment: RAPICIDE GLUTERALDEHYDE