ETHICON ENDO-SURGERY, LLC. OPT BLADELESS 5X100 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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Catalog Number 2B5LT |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Date sent: 4/11/2024.D4: batch # a9d717.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 2b5lt device was received with the sleeve broken.The piece broken from the sleeve was returned.In addition, the packaging opened was returned along with the instrument.No conclusion could be reached regarding what may have caused the reported incident.One possible cause for the damage found may be due to excessive force being applied to the device.Please refer to the instructions for use for additional information regarding proper device usage.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.
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Event Description
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It was reported that during a lap gastrectomy surgery, after insert into the trocar, noted the device was broken.Another device was used to continue the surgery.There was no patient consequence reported.No additional information can be provided.
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Search Alerts/Recalls
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