MAUDE Adverse Event Report: MEDIVATORS DSD-201; AUTOMATED ENDOSCOPE REPROCESSOR

Model Number DSD-201

Device Problems Improper or Incorrect Procedure or Method (2017); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Medivators technical service representative (tsr) was notified by the facility that they were modifying and altering dsd hook-up connectors and they reported not using the appropriate hook-ups as indicated for various scope models.They reported that if there was an unused connector on a hookup, they would pinch it off assuming fluid flow would be forced to the other endoscope channel connections.It was reported that this has been going on for over a year.Medivators dsd-201 hook-up connectors are designed and validated with all connectors appropriately connected to the scope.If used as intended there should never be a connector unused.Using a pinch clip to modify the hook-up is a contraindicated use of the connector.Medivators tsr informed the customer of the importance of the correct use of hook-ups with the aer and recommended they order the appropriate hook-ups.This facility does not have a service agreement/extended warranty so medivators field staff has not made any recent visits to this facility.To date, there have not been any reported illness or injuries to patients.This complaint will continue to be maintained within medivators complaint handling system.

Event Description

It was reported by a facility that they have been modifying and altering dsd-201 aer hook-up connectors for use in reprocessing endoscopes.Adulterations and modifications to hook-up connectors is a contraindicated use as listed in the hook-up and aer ifu.This could potentially lead to cross contamination between patients due to improper reprocessing of endoscopes.

• Brand Name: DSD-201
• 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: 6121024
• MDR Text Key: 60686438
• Report Number: 2150060-2016-00047
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DSD-201
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2009
• 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