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

Model Number CER-1

Device Problems Device Reprocessing Problem (1091); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 09/15/2014

Event Type  No Answer Provided  

Event Description

Facility is reprocessing olympus maj-855 auxiliary flushing tube connected to endoscope in the medivators cer-1 automated endoscope reprocessor which is not validated to prove high level disinfection.Potential cross contamination risk.

Manufacturer Narrative

The case states that during a visit medivators senior clinical specialist reported that this facility was reprocessing the olympus maj-855 flushing tube in a medivators cer-1 automated endoscope reprocessor while connected to the endoscope.This method of reprocessing the olympus maj-855 is not validated.It is unknown as to whether these scopes were high level disinfected and such reprocessing is not endorsed by olympus and medivators.There is potential risk of cross contamination to patients that receive procedures using these scopes and flushing tubes because of potential inadequate disinfection.Medivator clinical specialist are still in contact with this facility in regards to training and ordering the appropriate connectors for reprocessing olympus maj-855 on its own in the cer-1.Medivators has a product bulletin informs customers/users of the requirements and limitations when reprocessing the olympus maj-855 auxiliary flushing tube in conjunction with medivators endoscope reprocessors.To date, there have been no reports of patient injury or illness.This complaint will continue to be monitored within medivators complaint system.

• Brand Name: MEDIVATORS MV-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: 4133477
• MDR Text Key: 4794482
• Report Number: 2150060-2014-00040
• 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: 09/15/2014
• Initial Date FDA Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2009
• 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
• Treatment: OLYMPUS MAJ-855