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

Model Number DSD EDGE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fungal Infection (2419)

Event Type  Injury  

Event Description

Medivators sales representative reported that patients were returning to the hospital post-bronchoscopy procedures with geotrichum infections.The most recently reported information indicates that these fungal infections are not related to endoscope reprocessing procedures.

Manufacturer Narrative

Medivators sales representative reported that patients were returning to the hospital post-bronchoscopy procedures with geotrichum fungal infections.The facility uses dsd edge automated endoscope reprocessors (aer) to reprocess their bronchoscopes.The site has been culturing scopes post-reprocessing and no scopes have tested positive for the organism.There has been no indication of failures with their medivators equipment used to reprocess endoscopes.The facility is currently investigating this issue and is investigating back historically for more cases of infection.There currently is construction going on at the hospital.Their aers are serviced by local biomedical technicians and not medivators field service engineers.The patients' current conditions and number of patients presenting infection are unknown.This complaint will continue to be maintained and monitored in the medivators complaint handling system.

• Brand Name: MEDIVATORS 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: kristin bergeson ; 14605 28th ave n; minneapolis, MN 55447
• MDR Report Key: 4880241
• MDR Text Key: 6057805
• Report Number: 2150060-2015-00018
• 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: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 06/30/2015

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: Other
• Device Model Number: DSD EDGE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2011
• 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): Hospitalization