ETHICON ENDO-SURGERY, LLC. ENDOPATH*ULTRAVERES NDL 120MM; ENDOPATH* INSUFFLATION NEEDLE
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Model Number UV120 |
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 Date 02/02/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information received: a photo was received for review.During the visual analysis the following was observed: the photo shows the original perforated packaging, with the tip of the instrument exposed.Based on the photo review, the event described is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.As part of our quality process all devices are manufactured, inspected, and released to approved specifications.The device history records were reviewed and certified by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.
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Event Description
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It was reported that during an unknown procedure, the customer received the product from the carrier and the item in question had the packaging violated, thus losing the sterility of the product.There were no patient consequences.
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Manufacturer Narrative
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(b)(4).Date sent: 4/13/2022.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that uv120 device was returned inside its package unopened.Upon visual inspection, it was observed that the tyvek from the packaging was damaged; it was noted to have a hole in the tyvek, the hole was noted to be from the inside out.Due to the damages found on the packaging, a possible cause for these conditions is due to improper handling during transit or storage.All ethicon product is 100% inspected prior to release.The information you provided is compiled monitored and reviewed on a routine basis for any associated trends.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.
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