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

Device Problem Fumes or Vapors (2529)

Patient Problem Chemical Exposure (2570)

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

It was reported by the facility a technician experienced inhalation exposure symptoms from rapicide pa high level disinfectant (hld) after removing an endoscope during the disinfection cycle from their dsd edge automated endoscope reprocessor(aer).The facility reported while running a cystoscope in the aer the distal tip was pointing upwards.As a result, hld was spraying out of the lid gasket area.The technician stopped the cycle to reposition the endoscope.While opening the lid, they inhaled fumes.Then, the technician sought medical attention for respiratory concerns.It was reported they are doing fine now.The user manual for dsd edge states that the distal end of the endoscope must not point upwards toward the floating lid and must be completely submerged when the basin is filled.The user manual also cautions users about opening the lid during the disinfection process as exposure to vapor can cause sensitization.The technician did not follow instructions.It is unknown if they were wearing the appropriate ppe while handling.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

It was reported by the facility a technician experienced inhalation exposure symptoms from rapicide pa high level disinfectant (hld) after removing an endoscope during the disinfection cycle from their dsd edge automated endoscope reprocessor(aer).

• 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: 8588122
• MDR Text Key: 144323069
• Report Number: 2150060-2019-00038
• 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: Patient Monitoring
• Type of Report: Initial
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• 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: 04/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2019
• 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: CYSTOSCOPE
• Patient Outcome(s): Other