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Catalog Number 0113230 |
Device Problem
Unintended Ejection (1234)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/27/2023 |
Event Type
malfunction
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Event Description
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As reported, during an unknown procedure, two capsure fixation device (device #1 and device #2) were used to fixate the mesh.It was reported that, two fasteners were deployed at the same time which was stacked up.There was no reported patient injury.
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Manufacturer Narrative
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As reported, the capsure fixation device deployed two fasteners at the same time.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.The instructions-for-use (ifu) supplied with the device adequately describe the proper technique for fastener delivery.The ifu states: ¿compress hand piece trigger in a single, complete and uninterrupted stroke to drive a permanent fastener through the mesh into the tissue.Keep consistent counter pressure on the tip of the device through the entire stroke.Release the trigger allowing it to return completely to its resting position.¿ and "use caution when applying the capsure¿ fastener over or in proximity to underlying bone, vessels, nerves, or viscera.Care should be taken not to use excessive counter pressure as this may damage the tissue, the material being fixated, and/or the device.".This mdr is submitted to represent capsure straight (device #1).An additional mdr was submitted to represent capsure straight (device #2).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 : not returned.
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Event Description
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As reported, during an unknown procedure, two capsure fixation device (device #1 and device #2) were used to fixate the mesh.It was reported that, two fasteners were deployed at the same time which was stacked up.There was no reported patient injury.Addendum: clarification received confirmed that only one capsure straight device (device #1) was used during the procedure which is reported to have fired two fasteners.As such there is no device #2 associated with this event.As reported, during an inguinal hernia repair procedure, a capsure fixation device was used to fixate the mesh.It was reported that during single deployment two fasteners were released.Note: this file represent device #1.
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Manufacturer Narrative
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As reported, the capsure fixation device deployed two fasteners at the same time.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.The instructions-for-use (ifu) supplied with the device adequately describe the proper technique for fastener delivery.The ifu states: ¿compress hand piece trigger in a single, complete and uninterrupted stroke to drive a permanent fastener through the mesh into the tissue.Keep consistent counter pressure on the tip of the device through the entire stroke.Release the trigger allowing it to return completely to its resting position.¿ and "use caution when applying the capsure¿ fastener over or in proximity to underlying bone, vessels, nerves, or viscera.Care should be taken not to use excessive counter pressure as this may damage the tissue, the material being fixated, and/or the device.".Addendum: h11: this supplemental mdr is submitted to update the event (b5) regarding the clarification that only one capsure straight device involved in the case/event and to provide evaluation results of a provided photo.Review of the photos provided shows two fasteners deployed together into the mesh.Based on the deployment it is possible the second fastener was deployed into the first fastener inadvertently or possibly a full stroke may not have occurred on the first deployment and upon the next actuation two fasteners were deployed.Based on the photo evaluation and investigation performed, the root cause cannot be determined.This mdr represents capsure straight (device #1).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Search Alerts/Recalls
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