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

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

Patient Problem Burning Sensation (2146)

Event Date 02/12/2018

Event Type  Injury  

Manufacturer Narrative

A medivators clinical education specialist (ces) reported exposure to fumes from the facility's reprocessing room where rapicide pa high level disinfectant was used with their dsd edge automated endoscope reprocessors.The ces reported the fumes were so strong he had to leave the room as his eyes began to burn and he began to cough.He also reported concerns that facility staff were having a difficult time being in the reprocessing room due to exposure to the fumes.The medivators ces visited the facility after reports from the facility of excessive fumes in the room.He reported that the room was very small and had very little air movement or ventilation.Medivators customers are required to have sufficient air changes of a minimum of 10 air changes per hour in the room to dissipate the chemical vapor.The following week, the facility informed the ces that they had their ventilation system fixed and the issue had been resolved.Medivators regulatory affairs followed up with the ces and the facility and they confirmed that no medical attention was sought by anyone from exposure to the fumes.This complaint will continue being monitored in medivators complaint handling system.

Event Description

A medivators clinical education specialist (ces) reported exposure to high levels of fumes from the facility's reprocessing room where rapicide pa high level disinfectant was used with their dsd edge automated endoscope reprocessors.The ces reported he had to leave the room as his eyes began to burn and he began to cough.He also reported concerns that facility staff were having a difficult time being in the reprocessing room due to exposure to the fumes.The facility had improper ventilation in the room required for sufficient air changes to dissipate the chemical vapor.

• 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: 7325614
• MDR Text Key: 101957522
• Report Number: 2150060-2018-00017
• 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: K914145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/08/2018

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: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other