OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12°, STERILE, SINGLE USE; HF-RESECTION ELECTRODES
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Model Number A22201C |
Device Problems
Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Nonstandard Device (1420)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 04/19/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Contrary to the information previously supplied, only two hf resection electrodes from the same model and lot were returned to the manufacturer for evaluation/investigation.The visual inspection confirmed that the loop wires at the distal end of the hf resection electrodes are broken off.Olympus america inc.("oai") is implementing a removal action of specified lot numbers of the monopolar hf resection electrodes a22201c and wa22037c.The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.Oai has initiated this removal action after receiving an increased number of complaints regarding loop wires breaking at the distal end of the referenced electrodes.Investigations have confirmed that loop wires can break during the intended use of the electrodes.As a result, a fragment may fall inside the patient and will need to be retrieved.Retrieval of the fragment could prolong the procedure and, under certain circumstances, could require additional surgical treatment.The investigation revealed that the loop wires of the affected electrodes were damaged during production.The cause of this damage is defective manufacturing equipment.The damaged loop wires cannot be detected by visual inspection.There has been no report to date of an adverse event or patient injury.However, in an effort to prevent a potential risk to patient health, oai is undertaking this action to remove the affected lot numbers.Oai's correction number according to 21 cfr 806.10 (c) (1): 2429304-4/18/2017-044r.
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Event Description
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Olympus was informed that during a therapeutic transurethral resection of the prostate (turp) procedure, the loop wires of four hf resection electrodes from the same lot broke off and fell inside the patient.No further information was provided but the intended procedure was successfully completed with another hf resection electrode and there was no report about an adverse event or patient injury.
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