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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS OLYMPUS; ENDOSCOPE, AC-POWERED AND ACCESSORIES
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OLYMPUS OLYMPUS; ENDOSCOPE, AC-POWERED AND ACCESSORIES Back to Search Results
Model Number A20976A
Device Problem Material Disintegration (1177)
Patient Problem Insufficient Information (4580)
Event Date 11/04/2020
Event Type  malfunction  
Event Description
Cystoscopic bridge from olympus was being inspected in sterile processing dept and was found to have metal shavings in the working channel.The device is a stainless-steel reusable device.Staff that was completing inspection notified nursing staff responsible for urologic instrumentation.Inventory of urologic bridges was then taken down for inspection and another bridge was found to have a similar issue.Affected instrumentation was taken out of service and olympus was notified.Manufacturer response for bridge, (brand not provided) (per site reporter).Service representative came in and took one of the affected devices to the quality department at olympus.Complaint number (b)(4) issued.Device will be returned to hospital upon completion of inspection by olympus.
 
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Brand Name
OLYMPUS
Type of Device
ENDOSCOPE, AC-POWERED AND ACCESSORIES
Manufacturer (Section D)
OLYMPUS
2400 ringwood ave
san jose CA 95131
MDR Report Key10851489
MDR Text Key216611168
Report Number10851489
Device Sequence Number1
Product Code GCP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/13/2020,11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberA20976A
Device Catalogue NumberA20976A
Device Lot Number176W-0031
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/13/2020
Device Age4 YR
Event Location Hospital
Date Report to Manufacturer11/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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