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

Model Number RCER-2R

Device Problems Device Reprocessing Problem (1091); Flushing Problem (1252); Device Rinsing Issue (2309)

Patient Problem Chemical Exposure (2570)

Event Date 03/30/2017

Event Type  Injury  

Manufacturer Narrative

It was reported by a medical facility that three patients were potentially experiencing chemical colitis symptoms after an endoscopy procedure.The facility requested their refurbished cer-2 automated endoscope reprocessor to be evaluated by medivators.Medivators clinical specialist visited the facility to investigate.It was reported the facility was not following the daily quality assurance procedure required prior to the first use of the machine each day in accordance with the cer aer user manual.The daily quality assurance procedure is required maintenance that the facility must perform to ensure the machine provides adequate fluid flow from the machine to the channels of an endoscope.Medivators clinical specialist also reported that the chemical colitis cases were never confirmed.There have been no reports of any other patients experiencing these symptoms since this reported incident.The cer was returned to medivators depot services for additional evaluation and preventative maintenance.This complaint will continue to be monitored in medivators complaint system.

Event Description

Facility reported three cases of patients potentially experiencing chemical colitis after endoscopy procedures.

• Brand Name: CER-2
• 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: 6524298
• MDR Text Key: 73782687
• Report Number: 2150060-2017-00022
• 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: 04/26/2017

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: No Information
• Device Model Number: RCER-2R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Initial Date Manufacturer Received: 03/30/2017
• Initial Date FDA Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2010
• 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): Required Intervention