MAUDE Adverse Event Report: MEDIVATORS MEDIVATORS DSD-201; AUTOMATED ENDOSCOPE REPROCESSOR

Model Number DSD-201

Device Problem Device Reprocessing Problem (1091)

Patient Problem Exposure to Body Fluids (1745)

Event Date 05/05/2015

Event Type  No Answer Provided  

Event Description

Medivators received report of a biomass, suspected to have come from the previous patient, that came out of an endoscope during an upper gi procedure.The facility used a medivators dsd-201 automated endoscope reprocessor (aer) to reprocess the endoscope.

Manufacturer Narrative

Medivators received report of a biomass, suspected to have come from the previous patient, that came out of an endoscope during an upper gi procedure.The facility used a medivators dsd-201 automated endoscope reprocessor (aer) to reprocess the endoscope.A medivators field service engineer (fse) performed an inspection of the aer and found it to be functioning properly.A medivators clinical specialist also scheduled an in-service with the facility.Patient condition is unknown at this time.To date, there have been no other complaints.This complaint will continue to be monitored in the medivators complaint handling system.

• Brand Name: MEDIVATORS DSD-201
• 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: 4816128
• MDR Text Key: 5920317
• Report Number: 2150060-2015-00015
• Device Sequence Number: 1
• Product Code: FEB
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 06/02/2015

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-201
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/06/2015
• Initial Date FDA Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2011
• 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