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

Device Problem No Apparent Adverse Event (3189)

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

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

The facility reported that there was water intrusion damage to their endoscopes.They reprocess their scopes in a dsd edge automated endoscope reprocessor (aer), thus potential damage to endoscopes could inhibit high-level disinfection.A scope that is used in a patient procedure that has not been properly high level disinfected could lead to patient cross-contamination.Medivators ra followed up with the facility and it was reported that 6 endoscopes potentially had water intrusion damage.The facility confirmed these endoscopes were sent back to the manufacturer for repair.The facility confirmed they are using the medivators veriscan leak test for leak testing in their manual cleaning process.The scopes "passed" the leak test prior to aer reprocessing.The veriscan will not detect a leak in the event that water intrusion has filled the leaks in the endoscope.It is unknown if the facility is using another mechanism to detect damage in their scopes.The cause for water intrusion has not been determined.Medivators has not gotten permission from the facility to evaluate their machine.They have not reported any functionality issues with the aer.It is unknown if any of the endoscopes that were potentially damaged were used in patient procedures.There have been no reports of patient injury or harm.This complaint will continue being monitored in medivators complaint handling system.

Event Description

The facility reported that there was water intrusion damage to their endoscopes.They reprocess their scopes in a dsd edge automated endoscope reprocessor (aer), thus potential damage to endoscopes could inhibit high-level disinfection.A scope that is used in a patient procedure that has not been properly high level disinfected could lead to patient cross-contamination.

• 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: ann moua ; 14605 28th ave n; minneapolis, MN 55447 ; 7633182956
• MDR Report Key: 8757620
• MDR Text Key: 149928030
• Report Number: 2150060-2019-00050
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2018
• 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: MEDIVATORS VERISCAN LEAK TEST
• Patient Outcome(s): Other