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The sample was not returned for evaluation.
Based on the not having the sample returned, a definitive conclusion cannot be made.
However, as reported an 11mm trocar was used and the surgeon did not maintain visualization of the product throughout the procedure.
The instructions-for-use recommends the use of a 12mm trocar with product code 0114680 and states, "visualization should be maintained throughout the course of the entire procedure.
" as such it is possible that the use of an 11mm trocar and not maintaining visualization of the device may have contributed to the issue reported.
To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in may, 2018.
The dates of event and implant are estimated based on the information entered on the medwatch form as exact dates were not provided.
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.
(b)(4).
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As reported per medwatch form (b)(4): "when using the mesh with the echo positioning system, the yellow plastic anchor fell off of the blue tubing inside of the patient (it fell off after the tubing was cut).
The surgical team searched the abdomen extensively with the laparoscope and checked the trocars, including checking under the rubber gasket of the 11mm optiview trocar that was used with the mesh system.
Radiology was called and a flat plate was taken of a second piece of the same mesh/positioning system.
The piece was not radiopaque and did not have a marker, so the surgeon opted not to x-ray that patient's abdomen.
The second piece was taken by the surgeon to show the patient's family.
" this was a hernia repair surgery.
The following was provided in follow up with the hospital contact: the case was a laparoscopic incisional repair.
The inflation tube was grasped at the retrieval loop with a carter thomason grasper.
The inflation assembly was used successfully to place the mesh.
As reported, the yellow anchor was not visualized during the inflation process.
As the surgeon was removing the inflation assembly "it got stuck in a port and as the surgeon attempted to remove it the small piece of plastic (yellow anchor) came apart and was lost.
" no additional medical or surgical intervention was administered to the patient.
The inflation assembly was not saved for return evaluation.
The surgeon is reported to be an experienced user of the echo ps inflation device.
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