ETHICON ENDO-SURGERY, LLC. OPT SLEEVE 5X100MM STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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Catalog Number 2CB5LT |
Device Problems
Gas/Air Leak (2946); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Date sent: 2/29/2024.D4: 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.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 during an unknown procedure, the seal was faulty, audible leak.Procedure completed successfully.No patient consequences.
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Manufacturer Narrative
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(b)(4).Date sent: 3/19/2024.D4: batch # unk.Investigation summary : the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the 2cb5lt device was returned with no damage in the external components.In addition, the packaging opened was returned along with the instrument.A leak test was performed and the device was noted to leak with the test probe inserted through the device.The device was disassembled in order to evaluate the condition of the seal.Upon disassembling, no anomalies were found.As each device is visually inspected and functionally tested during the manufacturing process, it could not be determined what may have caused the reported incident.No conclusion could be reached as to what might have caused the reported event.The reported complaint was confirmed.A manufacturing record evaluation was performed for the finished device lot 739c66 number, and no non-conformances were identified.
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Search Alerts/Recalls
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