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)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/11/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect medical device has not yet been returned to the manufacturer 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 the prostate (turp) procedure, it was noticed that the loop wire at the distal end of the hf resection electrode had broken off.It is unknown if any device fragment fell inside the patient's bladder.However, it was assumed that it was flushed out with irrigation fluid since no foreign objects were discovered inside the bladder.There was no adverse event or patient injury.
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Manufacturer Narrative
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The suspect medical device was returned to the manufacturer for evaluation/investigation.The visual inspection confirmed that the loop wire at the distal end of the hf resection electrode is 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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