Visiport Plus 176674PFRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884521080768), received between Apr 17, 2017 and Jul 24, 2023 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PARTIAL NEPHRECTOMY PROCEDURE, WHEN MAKING THE ABDOMINAL ACCESS WITH THE DEVICE, THE LENS DISENGAGED. THE LITTLE PLASTIC CAP AT THE DISTAL END AND THE BLADE FELL INTO THE SUBCUTANEOUS TISSUE, WERE PICKED UP WITH GRASPERS, AND WERE ABLE TO BE RETRIEVED. IT WAS NOTED THAT EVERYTHING WAS PRESENTED AS NORMAL AND NO EXTRA STRENGTH WAS NECESSARY TO OPERATE THE DEVICE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379797 ↗
• InjuryJan 10, 2023Failure to Cut; Adverse Event Without Identified Device or Use Problem; Firing Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem; Firing Problem

  ACCORDING TO THE REPORTER, DURING A DIAGNOSTIC LAPAROSCOPY, WHILE ENTERING THE ABDOMEN, THE BLADE DID NOT CUT EFFECTIVELY LEADING TO EXCESSIVE FORCE BEING USED. THERE WAS NOTED BOWEL AND BLOOD VESSEL DAMAGE AND THE SURGEON HAD TO CONVERT TO AN OPEN PROCEDURE TO REPAIR, LOCATE AFFECTED ARTERY, AND HALT BLEEDING. THE EVENT LEAD TO A BLOOD LOSS OF MORE THAN 500 MILLIMETERS REQUIRING BLOOD TRANSFUSION, AN INCISION LENGTHENED TO MORE THAN 1 INCH, AND PROLONGED SURGICAL TIME OF MORE THAN 30 MINUTES. THE PATIENT HOSPITALIZATION WAS ALSO EXTENDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 16132974 ↗
• MalfunctionMar 24, 2022Break; Leak/Splash; Break; Leak/Splash

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE IS LEAKING WHILE BEING USED ON THE PATIENT AND WAS SUSPECTED TO HAVE A CRACK SOURCING THE LEAK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13876004 ↗
• MalfunctionSep 22, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, ON OPENING AND ACCESSING FIRST STEP, THE DEVICE SEAL WAS DAMAGED. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12512866 ↗
• MalfunctionApr 20, 2021Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, THE DEVICE SEAL WAS DAMAGED. THE DEVICE WAS FILLED WITH FLUID UPON ENTRY AND OBSCURED THE VISUALIZATION ON THE CAMERA. THE PRODUCT WAS PULLED OUT AND USED ANOTHER DEVICE INSTEAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11698023 ↗
• MalfunctionAug 27, 2020Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, ONE UNIT HAD AN ISSUE OF LENS DISENGAGED AND SEAL DAMAGED AND THE OTHER FOUR UNITS HAD SEAL DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10460473 ↗
• MalfunctionAug 27, 2020Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, ONE UNIT HAD AN ISSUE OF LENS DISENGAGED AND SEAL DAMAGED AND THE OTHER FOUR UNITS HAD SEAL DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10460424 ↗
• MalfunctionAug 27, 2020Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, ONE UNIT HAD AN ISSUE OF LENS DISENGAGED AND SEAL DAMAGED AND THE OTHER FOUR UNITS HAD SEAL DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10458623 ↗
• MalfunctionAug 27, 2020Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, ONE UNIT HAD AN ISSUE OF LENS DISENGAGED AND SEAL DAMAGED AND THE OTHER FOUR UNITS HAD SEAL DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10458612 ↗
• MalfunctionAug 18, 2020Difficult to Insert; Packaging Problem; Difficult to Insert; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, WHILE INSERTING THE DEVICE THROUGH THE ABDOMINAL WALL, THE DISTAL EDGES OF THE CANNULA FRACTURED.

  Patient problems: No Information

  MAUDE report 10422535 ↗
• MalfunctionJul 20, 2020Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, WHEN THE TROCAR WAS BEING PLACED THROUGH THE SKIN DURING A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS, TROCAR WOULD NOT ADVANCE THROUGH THE PORT. OPENED A SECOND DEVICE WHICH HAD THE SAME ISSUE, OPENED A THIRD DEVICE AND PROCEEDED WITH PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10294493 ↗
• MalfunctionFeb 15, 2019Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE SURGEON COULD EASILY PULL THE TRIGGER, BUT THE KNIFE BLADE WAS NOT CUTTING THE TISSUE. THIS HAPPENED WITH 3 DIFFERENT TROCARS. THEY USED A NEW DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8344777 ↗
• MalfunctionJan 14, 2019Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE SURGEON COULD EASILY PULL THE TRIGGER, BUT THE KNIFE BLADE WAS NOT CUTTING THE TISSUE. THIS HAPPENED WITH 3 DIFFERENT TROCARS. THEY USED A NEW DEVICE TO RESOLVE THE ISSUE ON ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8246056 ↗
• MalfunctionJan 8, 2019Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE SURGEON COULD EASILY PULL THE TRIGGER, BUT THE KNIFE BLADE WAS NOT CUTTING THE TISSUE. THIS HAPPENED WITH 3 DIFFERENT TROCARS. THEY USED A NEW DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8229885 ↗
• MalfunctionJul 24, 2018Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC BYPASS, THE INITIAL ENTRY OF THE DEVICE WAS COMPLETED AND UPON REMOVAL OF THE CAMERA AND TROCAR, A PIECE WAS SEEN FALLING ONTO THE DRAPES. THE INSPECTION BY THE STAFF COULD NOT DETERMINE WHERE THE PIECE CAME FROM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7713636 ↗
• InjuryJul 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE. THE SURGEON USED THE DEVICE WITH A LAPAROSCOPE TO GAIN ENTRY INTO THE ABDOMEN. THE SURGEON MADE A SMALL INCISION AND THE DEVICE WAS PUSHED AGAINST THE SKIN. THE DEVICE WAS FIRED MULTIPLE TIMES, CUTTING THROUGH LAYERS OF FAT AND MUSCLE. WHEN THE DEVICE HANDLE WAS REMOVED AND THE LAPAROSCOPE WAS INTRODUCED THROUGH THE CANNULA INTO THE ABDOMINAL CAVITY, VISIBILITY INSIDE THE ABDOMEN WAS LOST DUE TO WHAT APPEARED TO BE BLEEDING. FOLLOWING SEVERAL ATTEMPTS, THE LENS OF THE LAPAROSCOPE WAS UNABLE TO CLEARED DUE TO WHAT APPEARED TO BE SUBSTANTIAL BLEEDING FROM THE ABDOMINAL CAVITY. THE INSUFFLATOR WAS TURNED OFF BUT VISIBILITY WAS NOT IMPROVED. THERE WAS A SUBSTANTIAL DECREASE IN BLOOD PRESSURE AND TWO ADDITIONAL SURGEONS WERE CALLED TO ASSIST. THE PATIENT RECEIVED SEVERAL BAGS OF BLOOD TRANSFUSIONS AND RECEIVED WHAT APPEARED TO BE AN EXTERNAL CARDIAC MASSAGE BY THE ANESTHETIST. AFTER APPROXIMATELY TWENTY MINUTES, BLEEDING WAS SUCCESSFULLY ARRESTED BY PACKING AND CLAMPING THE INJURED BLOOD VESSEL (EMERGENCY LAPAROTOMY WAS PERFORMED). IT WAS STATED THAT THE PATIENT SUFFERED MASSIVE BLOOD LOSS DUE TO AN INJU

  Patient problems: Blood Loss; No Code Available

  MAUDE report 6740845 ↗
• MalfunctionApr 17, 2017Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC PROCEDURE THE KNIFE DID NOT FIRE OUT AS IS EXPECTED. TO COMPLETE THE PROCEDURE, A NEW DEVICE WAS USED. THERE WAS NO HARM CAUSED TO THE PATIENT. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6498579 ↗