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

Model Number DSD-3001

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

It was reported by the facility that three endoscopes were used on a patient with suspected variant creutzfeldt-jakob disease (vcjd) and then reprocessed in their dsd edge automated endoscope reprocessor (aer); thus there is a risk for cross contamination to subsequent patients.Medivators technical service advised the facility to discontinue use of their aers and endoscopes if there is suspected case of vcjd.It is unknown if the facility followed these instructions.Ra attempted contacting the facility.They did not confirm the suspected case of vcjd; they had started using their machines again as instructed by their operations team.The current patient condition is known.No adverse events were reported.This complaint will be continued to be monitored in the medivators complaint system.

Event Description

It was reported by the facility that three endoscopes were used on a patient with suspected variant creutzfeldt-jakob disease (vcjd) and then reprocessed in their dsd edge automated endoscope reprocessor (aer); thus there is a risk for cross contamination to subsequent patients.

• Brand Name: DSD EDGE
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer Contact: lauren johnson ; 14605 28th ave n; plymouth, MN 55447
• MDR Report Key: 8037277
• MDR Text Key: 126083565
• Report Number: 2150060-2018-00068
• 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: Biomedical Engineer
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DSD-3001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/21/2011
• 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