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

Model Number CER

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 09/17/2014

Event Type  No Answer Provided  

Event Description

The case states that the facility is reprocessing the olympus maj-855 in a medivators cer automated endoscope reprocessor.This machine is not validated to reprocess this tubing while connected to the endoscope.Potential cross contamination.

Manufacturer Narrative

The case states that the facility is reprocessing the olympus maj-855 in a medivators cer automated endoscope reprocessor.This machine is not validated to reprocess this tubing while connected to the endoscope.Potential cross contamination.Medivators clinical specialist informed the facility of this improper process and provided the medivators product bulletin.She is still in contact with this facility.To date, there are no reports of patient injury or illness.This complaint will continue to be maintained within medivators complaint system.

• Brand Name: MEDIVATORS CER
• 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: 4168662
• MDR Text Key: 5089186
• Report Number: 2150060-2014-00041
• 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: 10/14/2014

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/17/2014
• Initial Date FDA Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2002
• 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: OLYMPUS MAJ-855 TUBING