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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30°, STERILE, SINGLE USE; HF-RESECTION ELECTRODES
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OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30°, STERILE, SINGLE USE; HF-RESECTION ELECTRODES Back to Search Results
Model Number WA22306D
Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/06/2019
Event Type  malfunction  
Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation / investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation / investigation or additional significant information becomes available, this report will be updated.
 
Event Description
Olympus was informed that during a therapeutic transurethral resection of a bladder tumor (turbt) procedure, the loop wire at the distal end of the hf resection electrode first got bent and was bent back into place several times, and then broke off and fell inside the patient.An x-ray examination was performed but no foreign objects were found inside the patient.The procedure was successfully completed using a similar device and there was no report about an adverse event or patient injury.As a precaution, a postoperative ct scan has been scheduled in order to locate the missing fragment.
 
Manufacturer Narrative
Device evaluation: the suspect medical device was not returned to the manufacturer for investigation but to olympus medical systems corporation (omsc), japan (returned to omsc on 2019-09-26).The investigation confirmed that the loop wire at the distal end of the hf-resection electrode is broken off, leaving sharp edges at the points of breakage.According to the information provided, the user first bent the loop wire prior to the procedure and bent back into place several times during the procedure.As a result of this mechanical force, the loop wire then broke off.As clearly stated as a warning note in the instructions for use, the user must never try to bend the distal tip of the hf resection electrode.The hf resection electrode is a precise mechanical and electrical device which is very sensitive to mechanical and electrical stress.Therefore, this event/incident was attributed to use error.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the hf resection electrode without showing any abnormalities.The case will be closed from olympus side with no further actions but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.
 
Event Description
Olympus was informed that during a therapeutic transurethral resection of a bladder tumor (turbt) procedure, the loop wire at the distal end of the hf resection electrode first got bent and was bent back into place several times, and then broke off and fell inside the patient.An x-ray examination was performed but no foreign objects were found inside the patient.The procedure was successfully completed using a similar device and there was no report about an adverse event or patient injury.As a precaution, a postoperative ct scan has been scheduled in order to locate the missing fragment.As a result, no foreign objects were noted inside the patient.
 
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Brand Name
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30°, STERILE, SINGLE USE
Type of Device
HF-RESECTION ELECTRODES
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg 22045
GM  22045
MDR Report Key9000999
MDR Text Key161202005
Report Number9610773-2019-00121
Device Sequence Number1
Product Code FAS
UDI-Device Identifier14042761051689
UDI-Public14042761051689
Combination Product (y/n)N
PMA/PMN Number
K100275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 11/11/2019
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 Expiration Date12/19/2023
Device Model NumberWA22306D
Device Catalogue NumberWA22306D
Device Lot Number1000037341
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/06/2019
Initial Date FDA Received09/12/2019
Supplement Dates Manufacturer Received11/06/2019
Supplement Dates FDA Received11/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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