CONMED UTICA ELEC,BLDE,LNG,EXT,INSULATD,40; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Model Number 138110 |
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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Event Description
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During incoming inspection, the distributor rejected this device, 138110, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.This will be reported as a malfunction with potential for injury upon reoccurrence.
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Manufacturer Narrative
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The reported event of ¿insufficient heat seal¿ is confirmed.Received two 138110 in original packaging.Lot number was verified.Performed a visual inspection of the device, there were no signs of a breach.Performed a functional inspection, the devices were dye leak tested which indicated that the packaging had an insufficient heat seal for only one of the devices.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.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the following: these devices should be inspected before and after each use.Visually examine the devices for obvious physical damage including: cracked, broken or otherwise distorted plastic parts.Damage including cuts, punctures, nicks, abrasions, unusual lumps, significant discoloration.We will continue to monitor for trends through the complaint system to assure patient safety.
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Search Alerts/Recalls
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