Visiport Plus 176674PRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521080652), received between Jul 25, 2016 and Mar 12, 2024 — classified as 5 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionSep 16, 2020Failure to Cut; Protective Measures Problem; Failure to Cut; Protective Measures Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC EXCISION OF LESION OF THE UTERUS, THE KNIFE BLADE WAS EXPOSED A LITTLE BIT AND DID NOT CUT SMOOTHLY. A NEW DEVICE WAS TAKEN OUT AND USED ACCORDING TO THE SURGEON'S JUDGEMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10544323 ↗
• MalfunctionJul 16, 2020Break; Packaging Problem; Break; Packaging Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE REAR END OF THE DEVICE WAS NOTED TO BE CRACKED OPEN. ALSO, THE SEAL WAS DAMAGED. THE PRODUCT WAS NOT USED TO THE PATIENT. ANOTHER DEVICE WAS OPENED INSTEAD AND USED WITHOUT ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 10282747 ↗
• MalfunctionNov 1, 2019Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE TIP OF THE DEVICE BROKE.

  Patient problems: No Information

  MAUDE report 9269656 ↗
• MalfunctionAug 29, 2019Mechanical Problem; Failure to Cut; Mechanical Problem; Failure to Cut

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HYSTERECTOMY, THE EXPOSURE OF KNIFE BLADE OF THE DEVICE WAS LITTLE. THE SKIN WAS UNABLE TO BE CUT, AND THE DEVICE WAS REPLACED. THE EVENT OCCURRED ON TWO DEVICES CONTINUOUSLY. A NEW ONE WAS OPENED AND THE OPERATION WAS COMPLETED WITHOUT PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8946691 ↗
• MalfunctionMar 22, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  ACCORDING TO THE REPORTER, WHEN INSERTING THE TROCAR DURING A LAPAROSCOPIC BARIATRIC SURGERY, NO MATTER HOW MANY TIMES THE SURGEON PULLED THE TRIGGER, THERE WAS NO FEELING THAT THE TISSUE FIBER WAS CUT WELL, AND THE TROCAR COULD NOT BE INSERTED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8444570 ↗
• MalfunctionDec 17, 2018Leak/Splash; Mechanical Problem; Detachment of Device or Device Component; Packaging Problem; Leak/Splash; Mechanical Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, WHILE INSERTION OF THE HANDLE¿S BLADED TIP INTO THE CANNULA DURING A LAPAROSCOPIC HERNIA REPAIR, THE KNIFE WAS DIFFICULT TO ADVANCE, THE LENS DISENGAGED, AND THE SEAL WAS DAMAGED. THE BLADED TIP GOT STUCK TWO-THIRDS OF THE WAY DOWN AS WAS LEAKING. A CHIP FROM THE TIP OF THE DEVICE BROKE OFF AND FELL INTO THE UMBILICAL INCISION AND WAS RETRIEVED WITH A GRASPER. THE CASE WAS COMPLETED USING THE FAULTY DEVICE (CANNULA INTACT). THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8171694 ↗
• MalfunctionNov 14, 2017Detachment Of Device Component; Mechanical Problem; Detachment Of Device Component; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC NEPHRECTOMY, THE DEVICE¿S KNIFE WAS DIFFICULT TO ADVANCE AND THE LENS WERE DISENGAGED. NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7027883 ↗
• MalfunctionNov 10, 2017Device Packaging Compromised; Device Packaging Compromised

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA, THE DEVICE'S SEAL WAS DAMAGED. SCRUB TECHNICIAN OPENED THE DEVICE AND IT WAS BROKEN. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7018142 ↗
• MalfunctionSep 6, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC RECTOSIGMOIDECTOMY. DURING INTRODUCTION OF THE PORT INTO THE ABDOMINAL WALL, A SMALL PIECE OF PLASTIC WAS VISIBLE IN THE TIP OF THE OBTURATOR AFTER 'FIRING' ONE TIME. THE PIECE OF PLASTIC WAS COMING FROM THE LENS OF THE OBTURATOR. THE LENS DISENGAGED FROM THE DEVICE, BUT DID NOT FALL INTO THE PATIENT CAVITY. TO COMPLETE THE PROCEDURE, ANOTHER TROCAR WAS USED. NO PATIENT INJURY OR EXTENSION IN SURGICAL TIME. PATIENT STATUS IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6845152 ↗
• MalfunctionMay 2, 2017Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THERE WAS AN ISSUE WITH TWO DIFFERENT DEVICES THAT WERE USED. THE BLADE WOULD NOT CUT AND THE STAPLER JAMMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6536637 ↗
• MalfunctionJul 25, 2016Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, THE BLADE OF THE GUN IS NOT CUTTING THROUGH THE TISSUE. ANOTHER VISIPORT WAS OPENED AND USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5820110 ↗