OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30°, STERILE, SINGLE USE; HF-RESECTION ELECTRODES
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Model Number WA22351C |
Device Problems
Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/28/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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Olympus was informed that during a therapeutic transurethral resection of bladder tumour (tur-bt) procedure, the roller ball at the distal end of the hf resection electrode broke off and fell into the patient¿s bladder.The broken off ball was reportedly retrieved but it is unclear whether fragments of the wire remained inside the patient.The intended procedure was then completed using a similar device and there was no report about an adverse event or patient injury.
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Manufacturer Narrative
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The suspect medical device was not returned to the manufacturer for investigation but to olympus medical systems corporation (omsc), japan (returned to omsc on 2019-12-12).The investigation confirmed that the roller ball at the distal end of the hf-resection electrode is broken off.There are burn marks both on the roller ball and the resection electrode¿s blue insulation tube.The fork tubes are no longer parallel and the electrode is bent at the proximal end.The type of damage found indicates that excessive force must have been applied to the resection electrode¿s distal end.As reported by the customer, the electrode was alternately used for coagulation and ablation during the procedure, which indicates intensified use of the resection electrode thus, this event/incident was attributed to use error.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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