The reported product is an unknown baxter peri-strips psd-v with gel.The device was not returned, and the lot number is unknown; therefore, a device.Analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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It was reported from an anonymous survey result that the percentage of patients that had leaks or bleeds following surgery using peri-strips with gel for the reinforcement of staple lines during bariatric surgical procedures was 1-3%.The physician reported ¿1-3% leak rate is the baseline leak rate for bariatric surgery in general (for me) without any reinforcement of staple line this would be lower but many pt come to me and do not want any 'foreign material' used in their surgery so that effect my leak rate.I am sure it would be lower if every pt had staple line reinforcement¿ (no further details).At the time of this report, no further detail was provided regarding if hospitalization was required, treatment for the event or the patient¿s outcome.No additional information is available.
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