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Visiport Plus 176774PRecalls & reported problems

Covidien LP · Optical Obturator · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521080782), received between Feb 24, 2017 and Oct 31, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (2 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

Device problems

  • Failure to Cut2
  • Break1
  • Detachment of Device or Device Component1

Patient problems

  • No Known Impact Or Consequence To Patient2
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 31, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, LAPAROSCOPIC REFERTILIZATION GYNE, UPON PLACEMENT OF THE TROCAR, THE GLASS OF THE OBTURATOR BROKE AND DISENGAGE, THAT IT COULD NOT BE USED ANYMORE. A NEW DEVICE WAS TAKEN TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9263870 ↗
  • MalfunctionDec 4, 2017Failure to Cut; Failure to Cut

    ACCORDING TO THE REPORTER, DURING ESOPHAGEAL MYOTOMY DAVINCI USING AN OPTICAL OBTURATOR. THE DEVICE WOULD NOT CUT. THERE WAS NO PATIENT HARMED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7079982 ↗
  • MalfunctionFeb 24, 2017Failure to Cut; Failure to Cut

    ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC AP RESECTION THE DEVICE WOULD NOT CUT THE TISSUE. THERE WAS NO HARM TO THE PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6356123 ↗

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Sources and updates

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