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

Device Problem Off-Label Use (1494)

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

Event Date 09/26/2019

Event Type  Injury  

Manufacturer Narrative

The facility reported using the incorrect hookup when reprocessing endoscopes in their dsd edge automated endoscope reprocessor (aer).There is potential that endoscopes were not properly high level disinfected, thus there is potential for patient cross-contamination.There were two reported instances of the facility using endoscopes in patient procedures that were reprocessed using the incorrect hookup.Medivators technical services representative informed the facility that high-level disinfection cannot be guaranteed if the incorrect hookup is used.The facility reported they are now using the correct hookup for this endoscope and have retrained their staff.Per the medivators dsd edge user manual, users are required to verify the correct hookup is used for the type of endoscope being reprocessed.There have been no reports of patient harm.This will continue being monitored in medivators complaint handling system.

Event Description

The facility reported using the incorrect hookup when reprocessing endoscopes in their dsd edge automated endoscope reprocessor (aer).There is potential that endoscopes were not properly high level disinfected, thus there is potential for patient cross-contamination.

• Brand Name: DSD EDGE
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave. n.; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC.; 14605 28th ave. n.; minneapolis MN 55447
• Manufacturer Contact: alex nelson ; 14605 28th ave. n; minneapolis, MN 55447 ; 6125058332
• MDR Report Key: 9225224
• MDR Text Key: 170793286
• Report Number: 2150060-2019-00066
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• 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?: Yes
• Date Manufacturer Received: 09/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2010
• 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