SILS Port SILSPT12Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884523002645), received between Jul 13, 2020 and Jul 13, 2020 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED IN BETWEEN OCTOBER 2009 AND AUGUST 2013, THE STUDY AIMS TO DETERMINE EFFECTIVENESS OF SINGLE INCISION LAPAROSCOPIC SURGERY AS A MINIMALLY INVASIVE SURGERY FOR PATIENT WITH RECURRENT DIVERTICULAR DISEASE. THE PATIENTS LIST IS A TOTAL OF 488 CONSECUTIVE PATIENTS TREATED BY SIGMOIDECTOMY BY SINGLE INCISION LAPAROSCOPIC SURGERY. POST-OPERATIVELY THERE WERE THREE PATIENTS WITH MINOR COMPLICATIONS WHICH IS SUBCUTANEOUS HEMATOMAS.

  Patient problems: Hematoma

  MAUDE report 10263392 ↗