MAUDE Adverse Event Report: MEDIVATORS DSD EDGE; AUTOMATED ENDOSCOPE REPROCESSOR

Model Number DSD EDGE

Device Problem Device Disinfection Or Sterilization Issue (2909)

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

Event Date 02/10/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Medivators field service engineer reported observance of dsd edge automated endoscope reprocessor hookup modification for the reprocessing of savary dilators.The off-label use of the hookups could result in improper high level disinfection and/or improper rinsing; therefore lead to patient cross contamination or chemical colitis.Medivators fse informed the facility of the importance of appropriate hookup connection.Medivators sales representative quoted the customer for the appropriate hookups.It is unknown how many dilators were reprocessed using the modified hookups.To date, there have been no known reports of patient illness or injury.This complaint will continue to be monitored within medivators complaint handling system.

Event Description

Medivators field service engineer observed the facility modifying and altering medivators dsd edge hookups for use in reprocessing savary dilators.This off-label use of the hookups is not in accordance with the hookup or aer ifus.Off-label use and modification to the hookups could result in improper high level disinfection and/or improper rinsing; therefore lead to patient cross contamination or chemical colitis.

• Brand Name: DSD EDGE
• 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: 5492595
• MDR Text Key: 40080917
• Report Number: 2150060-2016-00011
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/09/2016

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: No Information
• Device Model Number: DSD EDGE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2015
• 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