OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°, STERILE, SINGLE USE; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
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Model Number WA22503D |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Internal Organ Perforation (1987)
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Event Date 05/25/2022 |
Event Type
Injury
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Manufacturer Narrative
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B3 - approximate date of (b)(6) 2022 was used as the event reportedly occurred about a year prior to notification.G4 - additional fda premarket submission number: k100275.The suspect device has not been returned to olympus.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.
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Event Description
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The customer reported to olympus that a patient experienced "bladder explosion" during a transuretheral resection of the prostate while using a hf-resection electrode, loop, 24 fr., 0.2 wire, large, 12°, sterile, single use, 12 pcs., for turis.The event reportedly occurred about a year prior to notification.Additional information is currently being requested for this event.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Attempts were performed to obtain additional information, but the customer confirm no other event details can be provided.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.Based on the results of the investigation, the reported event may be attributed to procedural complication during operation.During resection, cutting and coagulation an explosive compound of hydrogen (h2) and oxygen (o2), also known as oxyhydrogen, is generated by thermal reaction of the rinsing liquid.Activation of the hf current in the presence of inflammable gases may cause the gases to ignite or explode.This may result in bladder perforation or puncture, exogenous burns or other injuries.Olympus will continue to monitor field performance for this device.
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