ETHICON ENDO-SURGERY, LLC. XCEL DILATING TIP TROCAR 5MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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Model Number D5ST |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch # r93x4l.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Additional information received: a photo was received for review.Upon visual inspection of one photo, the following was observed: the photo shows a trocar device from top view inside of a plastic bag and no damage could be observed.Based on the photo reviewed, the event described cannot be confirmed.
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Event Description
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It was reported that during an unknown procedure, the shield reset button was non-functional when inserting through the "peritoneal." "patient was reported to be ok.".
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Manufacturer Narrative
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(b)(4).Date sent: 3/4/2020.D4: batch # r93x4l.H10=corrected data=d10.D10: date device returned to manufacturer was actually 2/10/2020 and not 1/30/2020.Investigation summary: the analysis results found that the d5st device was returned with no damage in the external components.During functional testing, the bullet retracted, permitting the exposure of the blade during the advancement through the skin test media and returned to safe position upon penetration.The bullet performed as intended without any anomalies noted.The event described could not be confirmed as the device performed without any difficulties noted.The reported complaint could not be confirmed.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances related to the reported complaint condition were identified.
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