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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL PRODUCTS CZECH8 HF-RESECTION ELECTRODE, 90; RESECTOSCOPE
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OLYMPUS MEDICAL PRODUCTS CZECH8 HF-RESECTION ELECTRODE, 90; RESECTOSCOPE Back to Search Results
Catalog Number A22253C
Device Problems Charred (1086); Flare or Flash (2942)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/07/2016
Event Type  malfunction  
Event Description
Dr was looking through cystoscopy using the monopolar resection electrode (a22253c) lot #15191p02l001 and stated he saw a blue flash.Dr removed resectoscope.Electrode tip charred and scope charred.Electrode replaced and scope replaced.Continued with procedure without complications.After procedure scope, cord, and bovie machine taken out of service.Scope and cord given to central sterile processing.Bovie ((b)(4)) given to biomed.Charred electrode placed on clinical leader's desk.
 
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Brand Name
HF-RESECTION ELECTRODE, 90
Type of Device
RESECTOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL PRODUCTS CZECH8
3500 corporate pkwy
center valley PA 18034
MDR Report Key5781688
MDR Text Key49157827
Report Number5781688
Device Sequence Number1
Product Code FJL
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 07/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue NumberA22253C
Device Lot Number15191P02L001
Other Device ID Number(01)04042761036825(17)200630(
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/07/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer07/07/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/11/2016
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
Treatment
NO OTHER THERAPIES
Patient Age79 YR
Patient Weight35
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