CONMED UTICA ELEC,BLDE,STD,EXT,INSULATED,40; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Catalog Number 138104 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Received five 138104 in unopened original packaging.Lot number was verified.Performed a visual inspection of the device, there were no obvious signs of a breach in the seal however, the device was encroaching into the seal.Performed a functional inspection, the devices were dye leak tested which indicated that the packaging had an insufficient heat seal on two of the five packages.Root cause cannot be determined, however, based upon a completed review of the manufacturing process, it indicated that a possible cause of this event could be due to a worn-out belt.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.(b)(4).Per the instructions for use, the user is advised to inspect and test each device before each use.Sterility guaranteed unless package has been opened, broken, or damaged.We will continue to monitor for trends through the complaint system to assure patient safety.
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Event Description
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During incoming inspection, the distributor rejected this device, 138104, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.Performed a functional inspection, the devices were dye leak tested which indicated that the packaging had an insufficient heat seal.This will be reported as a malfunction with potential for injury upon reoccurrence.
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Search Alerts/Recalls
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