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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, 12°, STERILE, SINGLE USE; HF-RESECTION ELECTRODES

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OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°, STERILE, SINGLE USE; HF-RESECTION ELECTRODES Back to Search Results
Model Number WA22302D
Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/16/2018
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 cervical neoplasm resection procedure, the loop wire at the distal end of the hf resection electrode broke off and fell inside the patient.The loop wire was reportedly not retrieved but an examination by x-ray showed no foreign objects inside the patient.No further information was provided, but there was no report about an adverse event or patient injury.
 
Manufacturer Narrative
The suspect medical device was not returned to the manufacturer for evaluation/investigation.Therefore, the evaluation was exclusively performed on the basis of the provided information.According to the available photo documentation, it could be confirmed that the broken loop wire at the distal end of the hf resection electrode was molten at both ends.The cause of this damage is most likely mechanical overload by the application of excessive force in combination with an unintended contact with other metal parts (e.G.Surgical instruments).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.
 
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Brand Name
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°, STERILE, SINGLE USE
Type of Device
HF-RESECTION ELECTRODES
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg
MDR Report Key8141163
MDR Text Key129610623
Report Number9610773-2018-00101
Device Sequence Number1
Product Code FAS
UDI-Device Identifier14042761051665
UDI-Public14042761051665
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 01/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/04/2023
Device Model NumberWA22302D
Device Catalogue NumberWA22302D
Device Lot Number1000025619
Was the Report Sent to FDA? No
Date Manufacturer Received12/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age54 YR
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