MAUDE Adverse Event Report: MEDIVATORS MEDIVATORS SSD-102; AUTOMATED ENDOSCOPE REPROCESSOR

Model Number SSD-102

Device Problems Device Reprocessing Problem (1091); Misconnection (1399); Improper or Incorrect Procedure or Method (2017)

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

Event Date 09/03/2014

Event Type  No Answer Provided  

Event Description

The case states that this facility is using incorrect hookups/ connectors in their medivators automated endoscope reprocessor.The hookup connections are not validated therefore, high level disinfection of the endoscope channels is not happening.Potential cross contamination risk.

Manufacturer Narrative

The case states that the medivators aer connectors/ hook-ups were being altered, modified, reassembled, and used with the incorrect endoscopes.Potential cross-contamination risk.Medivators clinical specialist reported these findings after a visit to this facility.To date, there is no reported patient or handler injury or illness.This complaint will continue to be maintained within medivators complaint system.

• Brand Name: MEDIVATORS SSD-102
• 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: 4125902
• MDR Text Key: 4920863
• Report Number: 2150060-2014-00038
• 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: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SSD-102
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2008
• 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