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

Medical Device Problem Code	Fumes or Vapors (2529)
Health Effect - Clinical Codes	Headache (1880); Chemical Exposure (2570)
Date of Event	08/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The facility reported a strong chemical smell from their dsd edge automated endoscope reprocessor (aer) causing operators to experience headaches.There is potential that operators are experiencing chemical exposure symptoms to fumes from rapicide pa high-level disinfectant used with the aer.Medivators field service engineer (fse) was dispatched to evaluate the aer and was not able to detect any chemical smell.While onsite, the fse noted poor air flow in the reprocessing room and determined the room does not have the minimum air changes as required for proper ventilation when using the aer.The fse also noted the facility had incorrect plumbing/water supply equipment for the number of aers in the reprocessing room, therefore the facility is not using the aers in accordance with medivators site requirements documentation.Upon completing the service intervention, the fse confirmed the aer is operating according to specification.Medivators regulatory attempted to follow up with the facility regarding the reported chemical exposures but no further information was provided.It is unknown if medical attention was sought.The facility was made aware of the site requirements prior to installing the aers and again after medivators fse was onsite during the recent service intervention.This complaint will continue being monitored in medivators complaint handling system.
Event or Problem Description
The facility reported a strong chemical smell from their dsd edge automated endoscope reprocessor (aer) causing operators to experience headaches.There is potential that operators are experiencing chemical exposure symptoms to fumes from rapicide pa high-level disinfectant used with the aer.

• Brand Name: DSD EDGE
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave. n.; minneapolis MN 55447
• MDR Report Key: 9124060
• Report Number: 2150060-2019-00064
• Device Sequence Number: 19537866
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: 00677964046674
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K092387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2019

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
• Operator of Device: No Information
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other