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

Model Number DSD-201

Device Problem Contamination of Device Ingredient or Reagent (2901)

Event Type  No Answer Provided  

Event Description

Facility reported to medivators that an endoscope with possible creutzfeldt-jakob disease contamination was reprocessed in a medivators dsd-201 automated endoscope reprocessor (aer).Three other scopes were subsequently reprocessed in the same aer and there is potential cross-contamination.Medivators told the facility that the scopes and aer have to be destroyed.

Manufacturer Narrative

Facility reported to medivators that an endoscope with possible creutzfeldt-jakob disease contamination was reprocessed in a medivators dsd-201 automated endoscope reprocessor (aer).Three other scopes were subsequently reprocessed in the same aer and there is potential cross-contamination.Medivators told the facility that the scopes and aer have to be destroyed.High level disinfection does not claim to inactivate prions and medivators' recommendation is for the endoscopes and aer to be decommissioned and destroyed if cjd exposure is suspected.It is unknown if the facility destroyed the aer or if it is still in use.To date, there have been no confirmed reports of additional patients contracting cjd.This potential high risk complaint will continue to be monitored and maintained within medivators complaint system.If additional information is received, this complaint will be reviewed.

Manufacturer Narrative

Facility reported to medivators that an endoscope with possible creutzfeldt-jakob disease (cjd) contamination was reprocessed in a medivators dsd-201 automated endoscope reprocessor (aer).Three other scopes were subsequently reprocessed in the same aer and there is potential cross-contamination.Medivators told the facility that the scopes and aer have to be destroyed.High level disinfection does not claim to inactivate prions and medivators' recommendation is for the endoscopes and aer to be decommissioned and destroyed if cjd exposure is suspected.Medivators contacted the facility and their infection control division determined that the cjd contamination was not confirmed and did not destroy the aer.To date, there have been no confirmed reports of additional patients contracting cjd.This potential high risk complaint will continue to be monitored and maintained within medivators complaint system.If additional information is received, this complaint will be reviewed.

Event Description

Facility reported to medivators that an endoscope with possible creutzfeldt-jakob disease (cjd) contamination was reprocessed in a medivators dsd-201 automated endoscope reprocessor (aer).Three other scopes were subsequently reprocessed in the same aer and there is potential cross-contamination.Medivators told the facility that the scopes and aer have to be destroyed.Medivators contacted the facility and their infection control division determined that the cjd contamination was not confirmed and did not destroy the aer.

• 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: 4828723
• MDR Text Key: 5905110
• Report Number: 2150060-2015-00017
• 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
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/15/2015

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2015
• Initial Date FDA Received: 06/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2006
• 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