ETHICON ENDO-SURGERY, LLC. OPT BLUNT TIP 12X100 SMOOTH; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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Catalog Number 2H12LP |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Date sent: 4/23/2024.B3: unknown, assumed first day of month that complaint was reported 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 port was disassembled during puncture.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
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Manufacturer Narrative
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(b)(4) date sent: 5/23/2024 d4: batch # a9e34w 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 the 2h12lp device was received with the olive plug assembly damaged.In addition, the broken part of the olive plug assembly were returned inside a plastic bag.As each device is visually inspected and functionally tested during the manufacturing process, no conclusion could be reached as to what might have caused the reported event.No conclusion could be reached as to what might have caused the reported event.The damaged on the olive plug assembly , it is possible that the damaged was due to an improper handling of the device.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
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