Visiport PlusRecalls & reported problems across all models

We found 5 models of Visiport Plus by Covidien LP in the FDA's device registry (GUDID). Together they are named in 55 adverse event reports in the FDA's MAUDE database, received between Jul 25, 2016 and Mar 12, 2024 — classified as 9 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Visiport Plus problems

Visiport Plus models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Visiport Plus 176674P

  Laparoscope, general & plastic surgery
  18 reports
• Visiport Plus 176674PF

  Laparoscope, general & plastic surgery
  17 reports
• Visiport Plus 176673P

  Laparoscope, general & plastic surgery
  9 reports
• Visiport Plus 176673PF

  Laparoscope, general & plastic surgery
  8 reports
• Visiport Plus 176774P

  Laparoscope, general & plastic surgery
  3 reports

Recent Visiport Plus adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2024Dull, Blunt; Protective Measures Problem; Dull, Blunt; Protective Measures Problem

  ACCORDING TO THE REPORTER, DURING A SLEEVE GASTRECTOMY PROCEDURE, WHEN CLICKING THE TRIGGER, THE KNIFE BLADE WAS ACTIVATED AT THE BEGINNING AND THEN DURING INSERTION IT STOPPED WORKING AND THE KNIFE WAS NOT CUTTING THROUGH THE TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18891762 ↗
• 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 ↗
• InjurySep 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC BARIATRIC ROUX-EN-Y, THE PLASTIC CAP (LENS) CAME OFF IN THE PATIENT PRE-PERITONEAL SPACE. THE SURGEON HAD PUT SOME FURTHER PORTS IN TO INVESTIGATE AND HAD TO USE AN L-HOOK TO GO THROUGH THE PERITONEUM (THROUGH DIATHERMY) TO RETRIEVE THE CAP IN THE ABDOMINAL CAVITY. A NEW PORT WAS OPENED TO RESOLVE THE ISSUE, BUT ENDED UP USING THE ORIGINAL PORT. THE EVENT LED TO TISSUE DAMAGE. THE INCISION WAS EXTENDED BY LESS THAN AN INCH.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15419524 ↗
• MalfunctionApr 26, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, AT THE START OF THE OPERATION, WHEN INSERTING THE DEVICE, THE SURGEON OBSERVED AN INFILTRATION OF LIQUID, POSSIBLY DUE TO A CRACK IN THE DEVICE. IT WAS ALSO STATED THAT THE LENS DISENGAGED. A NEW DEVICE WAS USED TO FIX THE ISSUE AND COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14214387 ↗
• MalfunctionApr 26, 2022Difficult to Insert; Mechanical Problem; Difficult to Insert; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A DIAGNOSTIC LAPAROSCOPY, WHILE ACCESSING STEP OF THE PROCEDURE, THE KNIFE WOULD NOT ERECT AND CUT, RESULTING IN DIFFICULTY TO ACCESS THE PATIENT CAVITY. IT WAS NOTED THAT THE SURGERY WAS EXTENDED BY 30 MINUTES OR MORE. THE SURGEON HAD REQUESTED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14213015 ↗
• MalfunctionMar 29, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE TOP PIECE OF THE TROCAR BROKE WHEN IT WAS INSERTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13942830 ↗
• 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 ↗
• InjuryMar 23, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC PROCEDURE, WHILE CLOSING THE SURGERY SITE IN THE ABDOMEN AREA OF THE PATIENT, IT WAS NOTICED THAT THE TROCAR BROKE INSIDE THE PATIENT, THE SURGEON WAS AWARE OF HIS ERROR AFTERWARDS. ENQUIRING TO SEE IF TROCAR PIECES CAN BE FOUND UNDER AN X-RAY SCAN.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 13862235 ↗
• InjuryDec 3, 2021Mechanical Problem; Retraction Problem; Mechanical Problem; Retraction Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HYSTERECTOMY, WHEN THE TRIGGER WAS PULLED, IT WAS FELT STIFFER THAN USUAL. THE KNIFE ON THE TIP REMAINED IN A STATE OF PROTRUDING. WHEN THE PNEUMOPERITONEUM STARTED AND THE PELVIS WAS LOWERED, THERE WAS A SUDDEN DROP IN BLOOD PRESSURE AT 40 MINUTES. AT PRESENT, WHILE THE ENDOTRACHEAL TUBE WAS BEING INSERTED, VENTILATION WAS BEING MANAGED AND THE PATIENT WAS UNDER OBSERVATION. THERE WERE RIGHT COMMON ILIAC ARTERY AND VEIN DAMAGE. BLOOD LOSS OF 500CC OR MORE DUE TO THIS PRODUCT PROBLEM AND NEEDED A BLOOD TRANSFUSION. EXTENDED SURGERY TIME OF MORE THAN 30 MINUTES OR MORE OCCURRED FOR PROCEDURE HAS TRANSITIONED TO EMERGENCY LAPAROTOMY. EXTENDED INCISION WAS ONE INCH OR MORE DUE TO DEVICE PROBLEM. HEMOSTASIS WAS PERFORMED BY CARDIOVASCULAR SURGERY AND SURGERY.

  Patient problems: Diminished Pulse Pressure; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12927848 ↗
• 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 ↗
• InjurySep 3, 2021Protective Measures Problem; Protective Measures Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE BLADE DID NOT RETRACT AFTER PENETRATING THE FASCIA, RESULTING IN A HOLE IN THE VENA CAVA. THE EVENT RESULTED IN MASSIVE BLOOD LOSS. OVER 40 UNITS OF BLOOD, FFP, PLATELETS AND CRYO WERE NEEDED TO STABILIZE THE PATIENT AND BE ABLE TO AIRLIFT PATIENT TO HIGHER ACUITY HOSPITAL.

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

  MAUDE report 12421936 ↗
• MalfunctionJun 29, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC OSTOMY REVERSAL PROCEDURE WHILE DISSECTING THE TISSUE, THE PLASTIC ON THE SHAFT OF THE LAPAROSCOPIC SCISSORS AND GRASPERS WERE CUT/SCORED WHILE IN THE TROCAR. IN ORDER TO RESOLVE THE ISSUE, THE SURGEON USED A DIFFERENT SCISSOR AND GRASPER TO FINISH THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12083902 ↗
• InjuryMay 5, 2021Break; Mechanical Problem; Sharp Edges; Break; Mechanical Problem; Sharp Edges

  ACCORDING TO THE REPORTER, UPON INSERTING THE TROCAR DURING A LAPAROSCOPIC BARIATRIC PROCEDURE, THE KNIFE WAS DIFFICULT TO ADVANCE AND THE DEVICE BROKE. THE DEVICE CUT ON THE SURGEON¿S HAND RESULTING TO AN EXTENDED SURGICAL TIME TO 30 MINUTES OR MORE SINCE. THE SURGERY WAS ALSO CANCELLED. THE SURGEON INCURRED A TEMPORARY INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11781078 ↗
• 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 ↗

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