SILS Port SILSPT5Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884523002638), received between Jul 8, 2020 and Jul 22, 2020 — classified as 10 injuries.

The most frequently reported specific device problem is “Difficult to Open or Close” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED FROM JANUARY 2012 TO DECEMBER 2013, CONSECUTIVE SERIES OF 26 PATIENTS WITH LOW RECTAL CANCER UNDERWENT LAPAROSCOPIC TATME COMBINED WITH TRANS-ABDOMINAL LAPAROSCOPIC SURGERY AND COLOANAL ANASTOMOSIS. SILS PORT AND THE VERSASTEP TROCAR WAS USED IN THE ABDOMINAL TECHNIQUE. POST-OPERATIVE COMPLICATIONS OCCURRED IN 26.9% (7 PATIENTS): 2 (7.7%) WITH ASYMPTOMATIC ANASTOMOTIC LEAKAGE; 2 PATIENTS WITH INTESTINAL OCCLUSION; 1 PATIENT WITH ACUTE URINARY RETENTION; 1 PATIENT HAD SYNCHRONOUS INGUINAL LYMPHADENECTOMY FOR RECTAL CANCER METASTASES AND SUFFERED OF LONG-LASTING LYMPHORRHEA.

  Patient problems: Failure to Anastomose; Occlusion; Urinary Retention

  MAUDE report 10307288 ↗
• InjuryJul 17, 2020Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN JANUARY AND MAY 2016, STUDY AIMED TO EVALUATE THE EARLY SURGICAL RESULTS FOLLOWING TOTAL MESORECTAL EXCISION TO TREAT RECTAL CANCER. TWELVE PATIENTS DIAGNOSED WITH MID-LOW RECTAL ADENOCARCINOMA WERE EVALUATED WITH REGARDS DEMOGRAPHY, HISTOPATHOLOGY, PERI-OPERATIVE DATA AND POSTOPERATIVE COMPLICATIONS. INTRAOPERATIVE COMPLICATIONS WERE RECORDED IN ONE CASE WITH THE FAILED MECHANICAL ANASTOMOSIS WHICH WAS RESOLVED BY PLACING ADDITIONAL INTERRUPTED STITCHES ON THE SUTURE LINE. FIVE OUT OF TWELVE PATIENTS UNDERWENT COLO-ANAL ANASTOMOSIS, 3 HANDSEWN AND 2 STAPLED. THE REMAINING WERE STAPLED COLORECTAL ANASTOMOSES. ALL ANASTOMOSES WERE PROTECTED WITH A DE-FUNCTIONING ILEOSTOMY. ELEVEN OUT 12 PATIENTS HAD LESS THAN 200 ML OF INTRAOPERATIVE BLOOD LOSS. THEY OBSERVED THE FOLLOWING EARLY POST-OPERATIVE COMPLICATIONS 1 CASE OF URINARY RETENTION, 1 OF PNEUMONIA, 2 SKIN INFECTIONS AND 2 POST-OPERATIVE ILEUS. TRANSANAL TOTAL MESORECTAL EXCISION (TATME): SINGLE-CENTRE EARLY EXPERIENCE IN A SELECTED POPULATION MICHELE DE ROSA1 · FABIO RONDELLI1 · MARCELLO BONI1 · FABIO ERMILI1 · WALTER BUGIANTELLA1 · LORENZO MARIANI1 · GRAZIANO CECCAREL

  Patient problems: Blood Loss; No Code Available; Pneumonia; Unspecified Infection; Urinary Retention

  MAUDE report 10287784 ↗
• InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED FROM FEBRUARY 2010 AND MAY 2014, POSTOPERATIVE FROM A TRANS-UMBILICAL LAPARO-ENDOSCOPIC SINGLE-SITE SURGERY (LESS) LIVING DONOR NEPHRECTOMY (LDN), EIGHT INFECTED WOUNDS WERE TREATED BY LOCAL TREATMENT. A PATIENT HAD NAUSEA, WHICH WAS TREATED MEDICALLY. ONE HAD PHLEBITIS OF THE LOWER LIMB, WHICH WAS TREATED MEDICALLY. ONE HAD INCISIONAL HERNIA, WHICH WAS TREATED SURGICALLY.

  Patient problems: Hernia; Nausea; Post Operative Wound Infection; Vasculitis

  MAUDE report 10268329 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED FROM FEBRUARY 2010 TO JUNE 2012, PREVIOUS PUBLICATIONS HAVE SUGGESTED THAT ENDOSCOPIC TRANSANAL PROCTECTOMY (ETAP) IS A PROMISING TECHNIQUE AND MAY BE AN ALTERNATIVE TO CONVENTIONAL LOW ANTERIOR RESECTION FOR RECTAL CANCER. THE AIM OF THIS STUDY WAS TO EVALUATE THE TECHNICAL FEASIBILITY OF ETAP, USING PORT DEVICES. FIFTY-SIX CONSECUTIVE PATIENTS (41 MEN) UNDERWENT ETAP. THE PORT WAS USED IN 11 CASES; HOWEVER, COMPLICATIONS WERE NOT REPORTED BY A SINGLE-PORT DEVICE. THE OVERALL POST-OPERATIVE COMPLICATION RATE WAS 26% (14/56). THREE PATIENTS DEVELOPED A CLINICAL ANASTOMOTIC LEAKAGE THAT DID NOT REQUIRE REOPERATION. THREE ADDITIONAL PATIENTS WERE DIAGNOSED WITH PELVIC SEPSIS WITHOUT EVIDENCE OF ANASTOMOTIC LEAK (2 OF THEM REQUIRED DRAINAGE UNDER CT SCAN), 5 PATIENTS EXPERIENCED TRANSIENT URINARY DISORDERS, 2 PATIENTS REQUIRED RED BLOOD CELL TRANSFUSION DURING THE POSTOPERATIVE COURSE, AND A (B)(6)-YEAR-OLD WOMAN SUFFERED FROM A CEREBRAL INFARCTION WITH A FAVORABLE OUTCOME. THE MEDIAN HOSPITAL STAY WAS 10 DAYS. ARTICLE: JEAN-JACQUES TUECH, 2015, ANNALS OF SURGERY VOLUME 261, NUMBER 2.

  Patient problems: Blood Loss; Failure to Anastomose; Infarction, Cerebral; No Code Available; Radiation Exposure, Unintended; Sepsis

  MAUDE report 10249732 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, (FEB-2014 TO SEP-2016) THIS STUDY AIMED TO EVALUATE SINGLE-INCISION LAPAROSCOPIC SURGERY WITH THE AIM OF DECREASING THE INVASIVENESS OF CONVENTIONAL LAPAROSCOPY. POST-OPERATIVE COMPLICATIONS WERE COMPARABLE BETWEEN GROUPS (9 (10.1%) SILC PATIENTS VS 4 (4.1%) TPLC PATIENTS) AND INCLUDED TWO WOUND INFECTION, ONE BILE LEAKAGE TREATED CONSERVATIVELY WITH ULTRASONOGRAPHIC GUIDED DRAINAGE AND ANTIBIOTICS, THREE UMBILICAL SEROMA, TWO HEMATOMA AND ONE SUBPHRENIC ABSCESS.

  Patient problems: Abscess; Hematoma; Post Operative Wound Infection; Seroma

  MAUDE report 10246228 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF A STUDY PERFORMED BETWEEN JUNE 2012 TO SEPTEMBER 2014 ABOUT SHORT-TERM OUTCOMES AND EXPERIENCE AFTER 80 CASES OF TRANSANAL TOTAL MESORECTAL EXCISION FOR RECTAL CARCINOMA, IN WHICH A SINGLE-PORT DEVICE WAS USED, ONE PATIENT WAS READMITTED 10 DAYS AFTER SURGERY WITH CIRCULAR FULL-THICKNESS ISCHEMIA OF THE MUCOSA DISTAL OF THE ANASTOMOSIS AND IN THE ANAL CANAL, POSSIBLY CAUSED BY PRESSURE NECROSIS DUE TO THE TRANSANALLY PLACED TROCAR.

  Patient problems: Ischemia; Necrosis

  MAUDE report 10245915 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF STUDY, LAPAROSCOPIC SURGERY FOR RECTAL CANCER HAS LOW RATES OF MORBIDITY AND MORTALITY AND ACHIEVES COMPARABLE PATHOLOGIC OUTCOMES. THE PURPOSE OF THE STUDY WAS TO COMPARE POST-OPERATIVE OUTCOMES OF SINGLE-ACCESS LAPAROSCOPIC SURGERY WHICH WAS PERFORMED AMONG 35 PATIENTS USING THE SILS PORT OR GLOVE PORT-SINGLE PORT, COMPARED WITH CONVENTIONAL LAPAROSCOPIC SURGERY WHICH WAS PERFORMED AMONG 36 PATIENTS WHICH USED THE LINEAR STAPLER. POST-OPERATIVE COMPLICATIONS OCCURRED IN 9 TOTAL PATIENTS. IN THE SALS GROUP, THERE WAS ONE CASE EACH OF WOUND INFECTION, EXACERBATION OF GOUTY ARTHRITIS, THROMBOPHLEBITIS, AND ATRIAL FIBRILLATION IN DIFFERENT INDIVIDUALS, AND THERE WERE TWO CASES OF DELIRIUM. IN THE CLS GROUP, THERE WERE TWO CASES OF WOUND INFECTION AND ONE OF THROMBOPHLEBITIS. PAIN SCORES WERE SIGNIFICANTLY HIGHER IN THE CLS GROUP AT BOTH 24 AND 48 H.

  Patient problems: Arthritis; Atrial Fibrillation; Post Operative Wound Infection; Vasculitis

  MAUDE report 10245776 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE, THE STUDY WAS TO EVALUATE THE SAFETY AND FEASIBILITY OF SINGLE-PORT COLORECTAL SURGERY. CONSECUTIVE PATIENTS UNDERGOING SINGLE-PORT COLORECTAL SURGERY WERE ENROLLED FROM 11 EUROPEAN CENTERS BETWEEN MARCH 2010 AND MARCH 2014. SOME 1769 PATIENTS WERE ENROLLED, 937 WITH BENIGN AND 832 WITH MALIGNANT CONDITIONS. CONVERSION TO OPEN SURGERY WAS REQUIRED IN 75 PATIENTS. INTRAOPERATIVE COMPLICATIONS WERE OBSERVED IN 29 PATIENTS WHICH INCLUDE; BLEEDING IN 13 PATIENTS, INJURY TO THE URINARY TRACT IN 7 PATIENTS, ENTEROTOMY IN 5 PATIENTS, AND SPLENECTOMY (OWING TO LACERATION, 1). IT WAS ALSO NOTED THAT SEVEN OF THESE PATIENTS, THE OPERATION WAS CONVERTED TO OPEN SURGERY. POSTOPERATIVE COMPLICATIONS WERE OBSERVED IN 224 PATIENTS, WHICH WERE PRESENTED BY COMPLICATION GRADE/CLASSIFICATION; AN ANASTOMOTIC LEAK, DIFFUSE PERITONITIS WITH THE PRESENCE OF FECAL FLUID AT REOPERATION, PRESENCE OF A LOCAL ABSCESS IN THE VICINITY OF THE ANASTOMOSIS; OR FECAL DISCHARGE FROM THE DRAIN OR WOUNDS.

  Patient problems: Abscess; Blood Loss; Injury; No Code Available; Peritonitis; Unspecified Infection

  MAUDE report 10245605 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, (APRIL 2009 TO JANUARY 2014) THIS STUDY AIMED TO EVALUATE A SINGLE-INCISION LAPAROSCOPIC SURGERY FOR RECTAL CANCER: EARLY RESULTS AND MEDIUM-TERM ONCOLOGICAL OUTCOME. IN A PROSPECTIVE STUDY 61 PATIENTS UNDERWENT SILS FOR RECTAL CANCER USING A SILS PORT. AN EARLY OR LATE POST-OPERATIVE COMPLICATION OCCURRED IN 12 (19.7%) OF THE 61 PATIENTS: PARALYTIC ILEUS (3), URINARY RETENTION (2), ANASTOMOTIC BLEEDING (2), HAEMATOMA FORMATION (2), WOUND INFECTION (1), INTRAPERITONEAL ABSCESS (1) AND URINARY TRACT INFECTION (1)], AND 3 READMISSIONS( 4.9%).

  Patient problems: Abscess; Hematoma; No Code Available; Post Operative Wound Infection; Urinary Tract Infection

  MAUDE report 10245560 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED DECEMBER 2012 AND JANUARY 2015, DURING LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL (TAPP) INGUINAL HERNIA REPAIR IS A FREQUENTLY PERFORMED METHOD. A RETROSPECTIVE STUDY BY ECE ET AL. EVALUATED THE SAFETY AND FEASIBILITY OF THE SINGLE-INCISION LAPAROSCOPIC SURGERY (SILS) APPROACH FOR LAPAROSCOPIC TAPP REPAIR OF THE INGUINAL HERNIA. FOR TAPP, A TROCAR WAS INTRODUCED THROUGH THE UMBILICUS WITH OPEN TECHNIQUE, WITH 3 OTHER TROCARS. THE RATES OF SHORT-TERM POST-OPERATIVE COMPLICATIONS WERE COMPARABLE BETWEEN THE GROUPS; SEROMA, AND HEMATOMA, AND ALL COMPLICATIONS WERE RESOLVED WITH CONSERVATIVE TREATMENT. THREE PATIENTS WERE TREATED WITH ORAL ANTIBIOTICS FOR PORT SITE INFECTION. THREE PATIENTS IN THE SILS-TAPP GROUP EXPERIENCED PORT SITE HERNIA (PSH).

  Patient problems: Hematoma; Seroma; Unspecified Infection

  MAUDE report 10245390 ↗