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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOQUICK DETERGENT; ACCESSORIES, CLEANING, FOR ENDOSCOPE
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OLYMPUS MEDICAL SYSTEMS CORP. ENDOQUICK DETERGENT; ACCESSORIES, CLEANING, FOR ENDOSCOPE Back to Search Results
Lot Number 203511
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem Insufficient Information (4580)
Event Date 02/22/2021
Event Type  malfunction  
Event Description
Incident description: around 1400: endoscopy staff were changing out some endoquick in the scope washing oer pro machines.When the cap was taken off the endoquick, staff noticed some unknown debris floating inside.Right away staff agreed to open another bottle of endoquick and noticed the floating debris inside that bottle.Also noticed more debris inside the endoquick bottles that were already being used from the earliest date (week prior).Then staff looked at the lot numbers and noticed all the bottles that had this debris inside all had the same lot number (203511) and expiration date (2022-06-30).Staff checked the rest of the endoquick bottles and found some with a different lot number.Opened one bottle and there was not debris.Opened two more bottles with the same lot number as the first one that had no debris, and they had no debris.
 
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Brand Name
ENDOQUICK DETERGENT
Type of Device
ACCESSORIES, CLEANING, FOR ENDOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
118 turnpike road
southborough MA 01772
MDR Report Key11412014
MDR Text Key234688768
Report Number11412014
Device Sequence Number1
Product Code FEB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/26/2021
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 Lot Number203511
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/26/2021
Event Location Hospital
Date Report to Manufacturer03/04/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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