This report is being filed as a voluntary distributor report.The manufacturer, unimax medical system, is responsible for performing the evaluation, investigation and any remedial actions related to this reported device issue.This issue will continue to be monitored through the complaint system to assure patient safety.
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Voluntary distributor report the sales representative reported on behalf of the customer that the sb957 was being used on (b)(6) 2020 during a bariatric surgery when small, plastic piece fell off inside the patient and was retrieved using laparoscopic graspers.This caused a 10-minute delay in the procedure.However, the procedure was completed as planned.There was no injury to the patient and no medical intervention or hospitalization.The patient is reported as current status of "good".This is an oem device owned by unimax medical system.This will be reported as a voluntary distributor report.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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