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); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 12/29/2022 |
Event Type
Injury
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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 patient's outcome 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, the loop wire at the distal end of the hf resection electrode broke off and fragments fell into the patient.One tiny fragment remained inside the patient since the surgeon was unable to retrieve it.The surgeon believes that this will pass in urine.The intended procedure was completed using the same set of equipment and there was no report about a patient injury.
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Manufacturer Narrative
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Additional information: d4 - lot number, h4 - device manufacturer date; device evaluation: the suspect medical device was returned to the manufacturer for investigation.The investigation confirmed that the loop wire at the distal end of the hf resection electrode had broken off.The cause of this event was attributed to wear and tear during use.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.Furthermore, the investigation found that the electrode showed deformations in all parts.These deformations were caused by external force and can thus be attributed to user error.The case will be closed on olympus side with no further actions.However, the reported phenomenon will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.
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