The event unit was returned to applied medical for evaluation.
Visual inspection of the returned unit confirmed the complainant¿s experience of seal component separation.
The shield, an internal plastic component of the seal, had separated from the seal.
Based on condition of the unit that was returned, the shield most likely dislodged as a result of non-axial insertion or removal of asymmetrical instrumentation through the sleeve.
Applied medical's instructions for use (ifu) states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.
All instruments should be centered axially when inserted through the seal to prevent tearing.
" this report is a combined initial and follow-up report.
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Name of procedure being performed: tatme.
Detailed description of event: i am reaching out to report a possible product failure in a tatme case at [name] hospital this morning.
The product i am reaching out about is ta211 (the gelpoint path w/ l hook) the case began at 8:30 am and ended at 1:00 p.
M.
The surgeon utilizing the gelpoint path was dr.
[name] assisted in the case by dr.
[name].
During the case, a small piece of clear plastic appearing to come from a trocar port attached to the gelpoint path came loose and was found in the patient¿s rectum.
The surgeon removed the small plastic piece from the port with a grasper.
There was no patient harm.
Additional information received via email on 25jun2019 from applied medical field assoc: the procedure was a tatme (transanal total mesorectal excision) the device was actually borrowed by [name] hospital from [name] hospital, to have in time for the procedure so that is why you are not finding it.
I reached out to my contact[name] for the lot number on the product.
She said that their risk management is assessing the situation before she can respond to me, but informed me that there was no patient harm.
I will give her a call again tomorrow to get more information.
Type of intervention: the surgeon removed the small plastic piece from the port with a grasper.
Patient status: there was no harm to the patient.
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