OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, SMALL, 12°, STERILE, SINGLE USE; HF-RESECTION ELECTRODES
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Model Number WA22301D |
Device Problems
Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/19/2023 |
Event Type
Injury
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Manufacturer Narrative
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The suspect medical device was not returned to olympus for evaluation/investigation since it was reportedly discarded by the user facility.Therefore, the exact cause of the patient¿s outcome and the reported phenomenon could not be determined and is being judged as unknown.Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (lot number) are missing.However, the reported electrode breakage is a known error phenomenon and can very likely be attributed to component failure caused by wear and tear.The electrode's loop wire wears out during use and may burn or melt if broken.The affected device can then lose broken parts.The case will be closed from olympus side with no further actions.However, the reported phenomenon will be recorded for trending and surveillance purposes.
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Event Description
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Olympus was informed that during a therapeutic transcervical resection (tcr) procedure, the loop wire at the distal end of the hf resection electrode broke off and fell into the patient.However, no fragment remained inside the patient since a ct scan was performed where no foreign objects were found inside the patient.The intended procedure was successfully completed with a similar device and there was no report about patient injury.
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Manufacturer Narrative
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This report is being supplemented to provide corrections to the initial with information inadvertently left out (a1, d8, e1 name, g2, and h6 type of investigation) and to provide correction to the initial (h3).The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Olympus will continue to monitor field performance for this device.
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