(b)(4).Maude report # 5076851.As a lot/batch was not provided, a device history could not be performed.The following information was requested, but unavailable: when removing the cyst and bag, did the surgeon make any accommodations to elongate the incision for specimen removal? nature of the cyst that was removed?.
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During a diagnostic laparoscopy and right cystectomy procedure; ¿utilizing ethicon endopouch specimen retrieval device, the cyst had ruptured and the device was used to collect the pieces of the cyst.The bag did break in the process of removing the device, but the surgeon thought all of the pieces of the bag were removed.Pt returned to the hospital with complaints of pain and fullness in the llq for laparoscopy, reduction and closure of incarcerated acute post op port site hernia, repair of bowel injury, removal of retained foreign body (a piece of the ethicon endopouch specimen retrieval bag.).
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