SILS Port SILSPT12TARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521102774), received between Apr 25, 2019 and Jan 31, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF APROSPECTIVE RANDOMIZED CONTROLLED STUDY OF OPERATIVE OUTCOMES OF SINGLE-INCISION LAPAROSCOPIC HYSTERECTOMY VERSUS CONVENTIONAL LAPAROSCOPIC TOTAL HYSTERECTOMY PERFORMED BETWEEN FEBRUARY 2016 AND OCTOBER 2019, 25 FEMALE PATIENTS UNDERWENT THROUGH SINGLE-INCISION LAPAROSCOPIC HYSTERECTOMY (SILH). POST-OPERATIVE MORBIDITY INCLUDE A PORT-SITE INFECTION AND PORT-SITE HERNIA.

  Patient problems: Hernia; Post Operative Wound Infection

  MAUDE report 16270760 ↗
• MalfunctionApr 25, 2019Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC TRANSANAL PROCEDURE, THE SURGEON EXPERIENCED BOTH RESISTANCE IN PLACING INSTRUMENTATION UPON ENTERING AND EXITING THE TROCAR. THEY THEN JUST DEALT WITH THE PROBLEM IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8552583 ↗