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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", 24 FR; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

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OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", 24 FR; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL Back to Search Results
Model Number WA22703S
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Type  malfunction  
Manufacturer Narrative
The device has not returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.As a preventive measure, the device instructions for use warns against bending the distal tip.The instructions for use also cautions, ¿if signs of wear become visible during the procedure, replace the product.¿ the instructions for use also have pre-procedure directions for inspecting both the device and its packaging for damage and deformation.
 
Event Description
Olympus was informed via medwatch report (b)(4) that during a cystoscopy with transurethral resection of prostate, the loop of the device broke in the middle and a fragment fell into the bladder.The fragment was washed out of the patient by flushing the bladder.There was no reported patient injury.
 
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Brand Name
HF-RESECTION ELECTRODE "PLASMALOOP", 24 FR
Type of Device
ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM  22045
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key8201480
MDR Text Key131916705
Report Number2951238-2018-00817
Device Sequence Number1
Product Code FAS
UDI-Device Identifier14042761085332
UDI-Public14042761085332
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171965
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/27/2018
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 Health Professional
Device Model NumberWA22703S
Device Lot Number1000022942
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/06/2018
Initial Date FDA Received12/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age68 YR
Patient Weight98
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