ETHICON ENDO-SURGERY, LLC. XCEL DILATING TIP TROCAR 12MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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Catalog Number D12LT |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/26/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Date sent: 1/18/2024.D4: batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Additional information was requested and the following was obtained: "during endoscopic lobectomy surgery that took place on (b)(6) 2023, the trocar in question was used and inserted into the patient's body between the ribs.At the end of the operation, when the surgeon removed the trocar from the patient's body (between his ribs), he noticed that the lower part of the trocar was broken.The surgeon performed scans in the surgical field in order to locate the fragments and remove them from the patient's body.The product with the fragments removed from the patient's body were transferred to us and will be sent to the manufacturer for analysis.After talking with the surgeon, to our understanding he does not believe that there are any fractures left in the patient's body"."there are not any known consequences or changes in the post-operative care of the patient as a result of the event".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 a lobectomy surgery (vats approach), when trocar was removed from patient, it was noticed to be broken.Scans in the surgical field were completed to locate and remove fragments from patients body.There is a possibility that they were not able to get all the fragments out.Procedure completed successfully.
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Manufacturer Narrative
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(b)(4).Date sent: 2/13/2024.Batch # unk.Additional information was requested and the following was obtained: "there are not any known consequences or changes in the post-operative care of the patient as a result of the event." 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 only the sleeve from the d12lt device was received with the sleeve broken.The broken piece from the sleeve and universal seal were returned inside a plastic bag.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.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
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