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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS BIPOLAR RESECTOSCOPE; CYSTOURETHROSCOPE
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OLYMPUS CORPORATION OF THE AMERICAS BIPOLAR RESECTOSCOPE; CYSTOURETHROSCOPE Back to Search Results
Catalog Number A22042A
Device Problems Break (1069); Detachment Of Device Component (1104); Retraction Problem (1536); Failure to Cut (2587)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/26/2016
Event Type  malfunction  
Event Description
The physician opted for transurethral resection of prostate (turp) due to issues of visualization of the green light laser.The physician proceeded with olympus continuous flow resectoscope set.It was noted that the loop was not cutting correctly and it was not retracting completely.During the resection, the physician noted a foreign body in the bladder.Upon examination it was the white plastic tip of the resectoscope.The physician attempted to retrieve the plastic tip that was in the bladder but due to poor visualization post-turp, could not retrieve it.Patient can currently urinate and wants to leave it in unless a problem occurs.
 
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Brand Name
BIPOLAR RESECTOSCOPE
Type of Device
CYSTOURETHROSCOPE
Manufacturer (Section D)
OLYMPUS CORPORATION OF THE AMERICAS
2400 ringwood avenue
san jose CA 95131
MDR Report Key6084913
MDR Text Key59390610
Report Number6084913
Device Sequence Number1
Product Code FBO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/04/2016
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 Physician
Device Catalogue NumberA22042A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/04/2016
Event Location Hospital
Date Report to Manufacturer11/04/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age84 YR
Patient Weight91
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