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

Device Problems Leak/Splash (1354); Device Emits Odor (1425)

Patient Problem Chemical Exposure (2570)

Event Date 03/30/2017

Event Type  Injury  

Manufacturer Narrative

It was reported by a medical facility that two operators of a dsd edge were experiencing respiratory/throat issues from a possible leak of rapicide pa disinfectant in the machine.They requested the machine to be evaluated for a leak.Medivators field service engineer (fse) evaluated the machine and reported there was a slight leak due to a defective o-ring on one of the reservoir tanks.Fse replaced the reservoir tank o-rings and the operation was tested and confirmed that the leak was fixed.Fse noted that the facility has ordered two active vapor management systems to improve ventilation in the room where rapicide pa is being used.The facility has noted ventilation issues in the past.No further patient/user update has been provided regarding the current status of the reported respiratory issues.There is no information regarding if operators of the machine were wearing appropriate ppe.This complaint will continue to be monitored with medivators complaint system.

Event Description

Facility reported operators of automated endoscope reprocessor were experiencing respiratory/throat issues from a possible leak of rapicide pa high level disinfectant in the machine.

• 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: 6515884
• MDR Text Key: 73495163
• Report Number: 2150060-2017-00021
• 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: Repair
• Type of Report: Initial
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: RAPICIDE PA
• Patient Outcome(s): Required Intervention