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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION RELIANCE; DISINFECTOR, MEDICAL DEVICES

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STERIS CORPORATION RELIANCE; DISINFECTOR, MEDICAL DEVICES Back to Search Results
Model Number SYNERGY
Device Problems Device Reprocessing Problem (1091); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Information (3190)
Event Date 08/25/2017
Event Type  malfunction  
Event Description
Or nurse submitted hero reports stating bioburden present on the loaner instruments they were getting ready to use for surgery.Found bioburden more than few trays in sterile processing department (spd).Staffs immediately pointed out their washers were not cleaning the instruments thoroughly.The devices were troubleshooted and nothing was found to be wrong with washers.Through the investigation, we found out spd technicians were not taking out the loaner instruments from the tray to scrub and pre-wash them.They would just throw in the tray in the washer without even opening them as it was brought by the representative and expected the washer to clean it out streak-free.Manufacturer response: for washers, synergy reliance (per site reporter) called steris and scheduled evaluation and maintenance service.
 
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Brand Name
RELIANCE
Type of Device
DISINFECTOR, MEDICAL DEVICES
Manufacturer (Section D)
STERIS CORPORATION
becky aldhizer
5960 heisley rd.
mentor OH 44060
MDR Report Key6955025
MDR Text Key89514614
Report Number6955025
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 09/13/2017,09/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberSYNERGY
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/13/2017
Device Age12 YR
Event Location Hospital
Date Report to Manufacturer09/13/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/17/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO OTHER THERAPIES
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