SILS Port SILSPT5TARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521102767), received between Nov 7, 2021 and Aug 22, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN 2021 AND 2017, TO CLARIFY THE ONCOLOGICAL SAFETY OF REDUCED-PORT LAPAROSCOPIC SURGERY (SINGLE-INCISION PLUS ONE PORT) (RPS) FOR PATIENTS WITH RECTAL CANCER. THERE WERE 63 PATIENTS SELECTED WITH CLINICAL STAGE I-III (T1-3 AND N0-2) RECTAL CANCER WHO UNDERWENT RPS OF RADICAL ANTERIOR RESECTION. THE PATIENTS WITHOUT A SCHEDULED OSTOMY, THE DEVICE WAS USED IN THE REGION OF THE UMBILICUS. ON THE PATIENT WITH PLANNED DIVERTING ILEOSTOMY, THE DEVICE WAS USED ON THE RIGHT LOWER ABDOMEN OF THE UMBILICUS. POSTOPERATIVE COMPLICATIONS INCLUDED WOUND INFECTION IN ONE (B)(4) PATIENT.

  Patient problems: Post Operative Wound Infection

  MAUDE report 20033173 ↗
• MalfunctionJan 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC PROCEDURE, A SMALL PIECE OF PLASTIC WAS NOTED IN THE PATIENT¿S ABDOMINAL CAVITY. THE ITEM WAS REMOVED AND AFTER THE LAPAROSCOPIC PORTION OF THE SURGERY WAS COMPLETED, THE PORTS WERE EXAMINED, AND IT WAS DETERMINED THAT THE PLASTIC PIECE ORIGINATED FROM THE INNER AREA OF ONE OF THE PORTS USED.

  Patient problems: Insufficient Information

  MAUDE report 13333799 ↗
• MalfunctionNov 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A SINGLE INCISION LAPAROSCOPIC SLEEVE (SILS) GASTRECTOMY, DURING GASTROINTESTINAL OPERATION, IT WAS FOUND THAT THE SEAL FRAGMENT HAD FALLEN INTO THE ABDOMINAL CAVITY. THE FRAGMENT WAS COLLECTED WITH FORCEPS UNDER MIRROR. WHEN THE SEAL WAS CHECKED, IT WAS CONFIRMED MISSING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12756098 ↗