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

Medical Device Problem Codes	Misconnection (1399); Maintenance Does Not Comply To Manufacturers Recommendations (2974)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	10/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A medivators clinical education specialist reported that the facility was requesting in-service training for their cer-2 automated endoscope reprocessors after the facility observed they had reprocessed scopes using a damaged hookup (clm-110-hu0129).Due to the damaged hookup being used during reprocessing, there is potential that scopes were not properly high level disinfected prior to patient procedures being performed.The facility identified two patients at risk for cross contamination exposure.The facility plans to notify these patients.The damaged hookup was destroyed and replaced with a new hookup.Since discovery of this issue, medivators ces provided in-service training at the facility on 10/05/2017 on the proper reprocessing of scopes using their cer machines and hookups.The condition of the two affected patients remains unknown.Medivators will continue to monitor this complaint in medivators complaint handling system.
Event or Problem Description
Medivators clinical education specialist reported that a facility was requesting a full in-service training for their cer-2 automated endoscope reprocessors after a damaged hookup was used during scope reprocessing.Due to the damaged hookup, there is potential that scopes were not properly high level disinfected.The facility has identified 2 patients who had procedures performed with scopes that were reprocessed with the damaged hookup.

• Brand Name: CER-2
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS, INC.; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 6935783
• Report Number: 2150060-2017-00045
• Device Sequence Number: 483004
• Product Code: NVE
• UDI-Device Identifier: 00677964052491
• UDI-Public: 00677964052491
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K871712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Replace,Notification,Inspection,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 10/10/2017

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other