Visiport Plus 176673PRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521080638), received between Mar 13, 2017 and Apr 26, 2022 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionAug 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY, A PIECE OF PLASTIC CAME OUT FROM THE DEVICE AND FELL INTO THE PATIENT CAVITY. TO RESOLVE THE ISSUE, THE SURGEON RETRIEVED THE PLASTIC PIECE USING GRASPER, AND USED ANOTHER DEVICE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10453158 ↗
• MalfunctionAug 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE LENS OF THE DEVICE DISENGAGED.

  Patient problems: No Information

  MAUDE report 8916605 ↗
• InjuryJul 17, 2019Break; Break

  ACCORDING TO THE REPORTER, THE DEVICE SHATTERED AND INJURED THE SURGEON.

  Patient problems: Injury

  MAUDE report 8798552 ↗
• MalfunctionJul 17, 2019Protective Measures Problem; Sharp Edges; Protective Measures Problem; Sharp Edges

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE WHILE INSERTING THE TROCAR, THE PLASTIC DOME THAT COVERS THE KNIFE BLADE BROKE EXPOSING THE KNIFE BLADE WHICH CUT THE SURGEON. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8798179 ↗
• MalfunctionFeb 8, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, THE DEVICE¿S PLASTIC PIECE FELL OFF ONTO STERILE FIELD. SURGEON WAS ABLE TO CONTINUE USING THE DEVICE TO COMPLETE THE NECESSARY PROCEDURAL STEPS. 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 7250992 ↗
• MalfunctionApr 12, 2017Leak/Splash; Device Packaging Compromised; Leak/Splash; Device Packaging Compromised

  ACCORDING TO THE REPORTER, THE SEAL OF THE PORT WAS DAMAGED AND LEAKING GAS. NO FURTHER DETAILS REGARDING THE PATIENT STATUS OR OUTCOME WERE PROVIDED. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6485821 ↗
• MalfunctionMar 13, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER: DURING A LAPAROSCOPIC PROCEDURE, THE LENS DISENGAGED FROM THE DEVICE DURING INSERTION. TO CORRECT THIS ISSUE, THE LENS WAS REMOVED FROM THE PATIENT CAVITY WITH GRASPERS. NO PATIENT INJURY.

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

  MAUDE report 6400714 ↗