ETHICON ENDO-SURGERY, LLC. XCEL DILATING TIP TROCAR 5MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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Catalog Number D5LT |
Device Problem
Dull, Blunt (2407)
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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).Only event year known: 2018.Batch # p92r4r.Device analysis: the analysis results of the d5lt found that it was received with the reset button in disarmed position.In addition, the tyvek(p4rl6w) from another device was returned along with the instrument.The instrument was armed and when the device was functionally tested the bullet did not retract as expected.No conclusion could be reached as to what may have caused the reported incident.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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During surgery, the dialating trocar knife has not been came out, port site insertion couldn¿t be proceed with blunt tip of trocar, so surgeon used new trocar.There were no patient consequences.
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Search Alerts/Recalls
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