Model Number G6313 |
Device Problem
Use of Device Problem (1670)
|
Patient Problem
Tissue Damage (2104)
|
Event Date 09/05/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
No product is being returned for evaluation and no lot # has been provided to manufacturer.A final report will be sent once the results have been analyzed.
|
|
Event Description
|
Name of procedure being performed: total abdominal hysterectomy.Dr performed a tah for large fibroid uterus and had been mobilising specimen before inserting alexis retractor during the procedure.Dr had packed away the bowel prior to inserting the inner ring but has made comment that she believes the inner ring caused bowel injury during the procedure.She found slight tearing of the sigmoid, transverse cut, later in the procedure but patient is doing well.Sales rep will be attending future tah cases where the surgeon wants to use the alexis with new sales rep to support surgeon and cover appropriate steps for insertion/removal.Patient status: slight tearing of the sigmoid, but patient is doing well type of intervention: unknown.
|
|
Manufacturer Narrative
|
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical has reviewed the details surrounding the event and related products.At this time, applied medical is unable to determine the cause of the injury or confirm that a product malfunction occurred.Applied medical will monitor its vigilance systems for any developing trends.
|
|
Event Description
|
Additional info received on 18oct2018 via email from territory manager: was there a reason that the alexis was not placed at the start of the procedure? dr.[name] placed alexis as soon as she has packed the bowel away - this is her technique.At what specific point of time during the procedure was the alexis placed? after the incision after bowel was packed away.At the time of placement was a finger sweep done under the placement ring to ensure no bowel entrapment? yes.How long was the alexis in place? 3.5 hours.When was this bowel injury noticed? after the alexis was removed.Was there any sharp instrumentation near the bowel? no.Was there any sheath tearing that occurred on the alexis unit? no.Additional information received on 01nov2018 via email from territory manager: i can confirm that should say patient is doing well post operatively.
|
|
Search Alerts/Recalls
|