ETHICON ENDO-SURGERY, LLC. HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36; INSTRUMENT, ULTRASONIC SURGICAL
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Model Number HARH36 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch # t94n65.Investigation summary the analysis results found that the harh36 device was returned inside its package unopened.Upon visual inspection, it was observed that the blister from the packaging was damaged.It was noted to be broken and still adhered to the tyvek.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.Due to the damages found on the blister, a possible cause for this condition is due to improper handling during transit or storage.It appears that the package hit a hard surface and this caused the reported event.The reported complaint was confirmed.All ees product is 100% inspected prior to release.
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Event Description
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It was reported that during an unknown procedure, before being used on the patient, the package was found damaged.Changed to another device to complete surgery.There was no patient consequence reported.No additional information can be provided.
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Search Alerts/Recalls
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