Secondary fda product code is (b)(4).Manufacturer narrative: the device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental, and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
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The customer reported that the device, ias12-100lpi, was being used during a laparoscopic assisted apr on (b)(6) 2020 when the small bowel was sucked up into the port.The port did not have any devices inserted at the time.This caused a small tear to the bowel, which required to be oversewn for medical intervention/repair.Per the reporter's form that was submitted, this was not considered an injury, rather only medical intervention.Also, the reporter did not consider this a fault or failure of the device due to the need for better placement of the port, and/or possible using a small millimeter sized port.The procedure was completed as planned, and there was no report of injury to the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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