Catalog Number CEV630-1A |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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This is 3 of 3 reports and is linked to mfg report numbers: 3003249645-2022-00039, 3003249645-2022-00040.A facility reported that following an insulation test, before the first use of the bipolar insert jaws (cev630-1a), the unit's dtug detected insulation defect.The insert/device was never sterilized or used on a patient.No patient injury, death or surgical delay has occurred.
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Manufacturer Narrative
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The bipolar insert jaws (cev630-1a) was returned to the manufacturer for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Evaluation of the bipolar insert jaws was unable to conclusively verify the complaint reported by the customer as valid; therefore, an investigation for cause was unable to be performed.The device passed the electrical test.No defect was found.Integra test is performed and validated to assure quality and safety with specific voltage.The hospital tested the device with a higher voltage, which is out of integra¿s specifications.The investigation did not highlight any defect.This complaint was unconfirmed.
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Event Description
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N/a.
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Manufacturer Narrative
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Updated fields: g3, g6, h2, h3, h10, h11
corrected field: h6 (medical device problem code).
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Search Alerts/Recalls
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