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

Model Number DSD-EDGE

Device Problem Insufficient Information (3190)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 05/05/2014

Event Type  No Answer Provided  

Event Description

Physician reported that after a procedure, a patient had burns that were not apparent at the start of the procedure.Potential case of chemical colitis.

Manufacturer Narrative

Physician reported that after an endoscopy procedure a patient had burns that were not apparent at the start of the procedure.Potential case of chemical colitis.Medivators field service engineer visited the facility and confirmed that the medivators dsd edge aer machine was running and rinsing scopes according to specifications.Test cycle were run to verify performance.Basins of the aer were tested for chemical reaction.It was reported that no errors were found.The cause of the burns on the patient are unknown.There is limited information available for this incident.This potential complaint will continue to be monitored within the medivators complaint system.

• Brand Name: MEDIVATORS 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 ; 7635533300
• MDR Report Key: 3841537
• MDR Text Key: 4659653
• Report Number: 2150060-2014-00019
• 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
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 05/28/2014

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: Other
• Device Model Number: DSD-EDGE
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: RAPICIDE PA