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

Model Number DSD-201

Device Problems Misconnection (1399); Improper or Incorrect Procedure or Method (2017)

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

Event Date 08/28/2014

Event Type  No Answer Provided  

Event Description

The case states that facility is using hookups with their endoscopes that have been completely altered/modified by user.The hookups are not validated for use in any medivators automated endoscope reprocessors.Potential for cross contamination.

Manufacturer Narrative

The case states that facility is using hookups/aer endoscope connectors that have been completely altered/modified by user.The hookups are not validated for use in any medivators automated endoscope reprocessors.Potential for cross contamination.This was reported by medivators field service engineer via field observation report and photographs.To date, there have been no reported injury or illness.This complaint will be maintained within medivators complaint system.

• Brand Name: MEDIVATORS 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: 4112940
• MDR Text Key: 4918453
• Report Number: 2150060-2014-00037
• 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: Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: DSD-201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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