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symphonX™ Hub Cap & Sealing UnitRecalls & reported problems

Fortimedix Surgical B.V. · Device for use in combination with the symphonX Introducer during minimally invasive abdominal laparoscopic surgical procedures · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08719324463171), received between Oct 4, 2019 and Oct 4, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Noise, Audible” (1 report).

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 18, 2026.

Most reported problems

Device problems

  • Noise, Audible1
  • Structural Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 4, 2019Structural Problem; Noise, Audible

    MICROLINE SURGICAL ENDOCUT SCISSOR TIP WAS REPORTED TO BE DULL BY DOCTOR AND REPORTED TO BE MAKING A CLICKING SOUND WHEN OPERATED BY STAFF. WHEN THIS WAS NOTICED A NEW SCISSOR TIP WAS GIVEN THAT WORKED FINE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9156833 ↗

Sources and updates

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