ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL OPTIVIEW; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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Catalog Number 2B12LT |
Device Problem
Crack (1135)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Event month and day: unknown.Event year: 2017.Batch # p91p32.Device analysis: the analysis results found that the 2b12lt device was received with the lens of the obturator fractured.It could not be determine what may have cause the reported event.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
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Event Description
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The trocar was opened by the surgeon during a lap sigmoidectomy procedure in cmc.The product has functioned normally during the whole case and was used as a working port during the procedure.After case completion and the product was removed from patient body, nurse noticed a small crack in the transparent silicon valve within the trocar channel.The defect was checked to be intact.There were no patient consequences.
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Manufacturer Narrative
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(b)(4).Per photographic evaluation: pictures of the sample were received for analysis.Upon visual inspection of the picture, the seal appears to be torn.Please refer to physical analysis for investigation on the returned sample.Device analysis: the analysis results found that the 2b12lt device was returned with no damage in the external components.Upon evaluation, the optiview slc assembly and was found torn.The device was disassembled in order to evaluate the condition of the seal and the damage was confirmed, was observed to have a mark which suggests that a pointy instrument was inserted through the trocar with excessive force.Per instructions for use: "use caution when introducing or removing instruments through the trocar sleeve in order to prevent inadvertent damage to the seals which could result in loss of pneumoperitoneum.Special care should be used when inserting sharp or angled edged endoscopic instruments to prevent tearing the seal.".
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Search Alerts/Recalls
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