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

Device Problems Off-Label Use (1494); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

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

Event Date 03/28/2018

Event Type  Injury  

Manufacturer Narrative

Medivators field service engineer (fse) discovered during a service visit that the operators of a dsd edge automated endoscope reprocessor were using incorrect hookups during endoscope reprocessing.There is potential that endoscopes were not properly high-level disinfected, thus potential for patient cross-contamination.It is unknown how long the facility was using incorrect hookups.Medivators fse informed the operators how to determine the correct hookup/endoscope combination.Medivators clinical education specialist (ces) has trained the facility staff on correct hookup use and proper reprocessing processes.Per the facility's request, medivators ces provided additional follow-up in-service training in response to this event.While medivators ces was in communication with the facility, it was also reported there is potential the facility was not performing proper filter maintenance in their machine as required per the dsd edge instructions for use.There have been no reports of patient harm.This complaint will continue to be monitored in the medivators complaint handling system.Facility information: (b)(6).

Event Description

Medivators field service engineer (fse) discovered during a service visit that the operators of a dsd edge automated endoscope reprocessor were using incorrect hookups during endoscope reprocessing.There is potential that endoscopes were not properly high-level disinfected, thus potential for 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: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 7454166
• MDR Text Key: 106290366
• Report Number: 2150060-2018-00032
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: 00677964046674
• 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: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• 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
• Patient Outcome(s): Other