ETHICON ENDO-SURGERY, LLC. ENDOPATH*PROBE PLUS II HANDLE; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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Model Number EPH04 |
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 12/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Date sent: 1/17/2023.Unknown; captured as awareness date.Batch #: v94j5y.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.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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It was reported that before an unknown procedure ¿the adhesive on the box separated so therefore it is no longer sterile.¿ no injuries or adverse event was reported.
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Manufacturer Narrative
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(b)(4).Date sent: 3/23/2023.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.The device was returned sealed in its original packaging.Upon visual inspection, a stain that appears to be oil was observed on the tyvek of the packaging and in this area, the tyvek came loose.No conclusion could be reached as to what caused the issue reported.All ees 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 the quality process all devices are manufactured, inspected, and released to approved specifications.
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Manufacturer Narrative
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(b)(4) date sent: 2/2/2023 this is an analysis of a set of images submitted for evaluation.Image 20221227_075010 and 20221227_074953: the image provided by the customer shows a sterile package.The seal appears to be damaged.Image 20221227_075000: the image provided by the customer shows a sterile package.No conclusion could be reached as to how this issue occurred through photo analysis.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.
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Search Alerts/Recalls
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