OLYMPUS WINTER & IBE GMBH JAWS "HIQ+", BIPOLAR, 5 X 330 MM, GRASPING FORCEPS, FENESTRATED; BIPOLAR GRASPING FORCEPS
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Model Number WA64120C |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/12/2023 |
Event Type
malfunction
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Event Description
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The customer reported that when using a jaws "hiq+", bipolar, 5 x 330 mm, grasping forceps, fenestrated, the forceps was broken, and the insulation was incomplete.The event occurred during preparation for use.The therapeutic laparoscopic procedure was completed with a similar device.There was no procedural delay, or no patient harm associated with the event.
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Manufacturer Narrative
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The device will not be returned for evaluation as it was suggested to dispose of the device since it cannot be repaired.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
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Manufacturer Narrative
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Updated fields: h6, h10.Corrected fields: d8/d9/h6 (3rd party repair).This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was not returned to olympus, but was inspected by a third party and the reported events were confirmed.The device history record was unable to be reviewed for this device and the manufacturer date is unavailable 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 root cause could not be determined.It is likely the damaged mechanism occurred due improper handling and the incomplete insulation was likely caused by unauthorized repairs by a third-party.Olympus does not recommend repair actions by unauthorized service centers.Olympus will continue to monitor field performance for this device.
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