Model Number A22201C |
Device Problems
Break (1069); Detachment Of Device Component (1104); Component Falling (1105)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/22/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The device was not returned to olympus for evaluation.The cause of the reported event could not be determined, however, based on similar reported complaints the most probable cause are as follows: the electrode loops are used to manipulate the surrounding tissue which can cause the loop wire to bend/break, electrical output settings on the electrosurgical generator are too high, and/or the loop wire comes in contact with metal during activation.If additional information becomes available or if the device is returned to olympus for evaluation at a later time, this report will be supplemented accordingly.
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Event Description
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Olympus was informed that the loop broke off the device and fell into the patient during a transurethral resection of a prostate tumor (turpt) procedure.The device fragment was retrieved from the patient with no issues.The intended procedure was completed using similar device.No patient injury was reported.The device will be returned to olympus for evaluation.
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Manufacturer Narrative
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The device was returned for evaluation.A visual inspection of the device noted the loop at the distal end was broken off and missing.The loop wire was not returned with the device.A microscope inspection was performed and revealed charring deposits at the tip of both yellow colored resection posts.There are small portions of the loop wire that remained and appeared to be melted which is an indication of thermal damage.Based on evaluation results and similar reported complaints, the most probable cause of the reported event could be due to the loop wire coming in contact with metal material during hf output which can attribute to melting and burning of the loop wire.
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Manufacturer Narrative
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The oem performed an evaluation for the reported lot number of the model a22201c hf resection electrode that was used and based on the oem¿s investigation it has been determined that the loop wires of the affected electrodes became damaged during production due to some irregularities in the manufacturing equipment.As a result, a field safety corrective action has been initiated to prevent potential risk to patient health.
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Search Alerts/Recalls
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