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

Device Problems Fumes or Vapors (2529); Ventilation Problem in Device Environment (3027)

Patient Problem Chemical Exposure (2570)

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

A facility reported staff experiencing eye irritation due to fume exposure to rapicide pa high level disinfectant (hld) , which is used in their dsd edge automated endoscope reprocessor (aer).Medivators field service engineer (fse) visited the facility to evaluate the machine.The fse confirmed the dsd edge machine was operating according to specification.The fse reported the facility recently installed this new aer which uses different hld (rapicide pa) than their previous machine.Upon installing the new machine, the facility elected not to install the vapor management system used with their previous machine.The fse also reported the new endoscope reprocessing room where this new machine is located is very small (8 ft.X 13 ft.) which requires adequate ventilation to minimize staff exposure to chemical vapors.The fse installed the vapor management system on the machine to capture fumes during cycle operation.Medivators site requirements documentation clearly states that it is the customer's responsibility to ensure the room has the minimum required 10 air changes per hour, as during cycle operation, chemical vapor may be produced.This is not a requirement of the dsd edge endoscope reprocessor but of the chemicals that are used for disinfection.Medivators regulatory followed up with the facility regarding the reported exposure.The facility reported that no severe adverse effects were experienced from the fumes and no medical attention was sought.The facility reported they "fan" out the scope room occasionally for additional relief.Medivators remains in close contact with the facility.This complaint will continue to be monitored in medivators complaint handling system.

Event Description

A facility reported staff experiencing eye irritation due to fume exposure to rapicide pa high level disinfectant, which is used in their dsd edge automated endoscope reprocessor.

• 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: 8262515
• MDR Text Key: 133717891
• Report Number: 2150060-2019-00003
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2018
• 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