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Habib 700-103659Recalls & reported problems

Navilyst Medical, Inc. · RITA Habib 4X Laparoscopic Electrosurgical Device · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H7877001036591), received between Dec 17, 2020 and Dec 17, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (4 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

Device problems

  • Activation Problem4

Patient problems

  • No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 17, 2020Activation Problem; Activation Problem

    FOURTH REPORTED HABIB PROBE: AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH 4 HABIB 4X LAPAROSCOPIC PROBES. THE PROBES GAVE EITHER "NO DEVICE CONNECTED" OR "POOR CONNECTION" ERROR MESSAGES. DURING A PROCEDURE, EACH PROBE FAILED TO FUNCTION SUCCESSFULLY WITH TWO SEPARATE GENERATORS. IN ORDER TO SECURE THE ABLATION, THE CASE WAS COMPLETED WITH A DIFFERENT DEVICE; HOWEVER, THIS RESULTED IN AN INCREASE OF ONE HOUR AND 30 MINUTES OF GENERAL ANESTHESIA TIME. THIS EVENT MEETS THE CRITERIA A REPORTABLE ADVERSE EVENT; PATIENT SAFETY RISK DUE TO PROLONGED PROCEDURE GREATER THAN 30 MINUTES (EXTENDED SEDATION). IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11030208 ↗
  • MalfunctionDec 17, 2020Activation Problem; Activation Problem

    SECOND REPORTED HABIB PROBE: AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH 4 HABIB 4X LAPAROSCOPIC PROBES. THE PROBES GAVE EITHER "NO DEVICE CONNECTED" OR "POOR CONNECTION" ERROR MESSAGES. DURING A PROCEDURE, EACH PROBE FAILED TO FUNCTION SUCCESSFULLY WITH TWO SEPARATE GENERATORS. IN ORDER TO SECURE THE ABLATION, THE CASE WAS COMPLETED WITH A DIFFERENT DEVICE; HOWEVER, THIS RESULTED IN AN INCREASE OF ONE HOUR AND 30 MINUTES OF GENERAL ANESTHESIA TIME. THIS EVENT MEETS THE CRITERIA A REPORTABLE ADVERSE EVENT; PATIENT SAFETY RISK DUE TO PROLONGED PROCEDURE GREATER THAN 30 MINUTES (EXTENDED SEDATION). IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11030149 ↗
  • MalfunctionDec 17, 2020Activation Problem; Activation Problem

    THIRD REPORTED HABIB PROBE: AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH 4 HABIB 4X LAPAROSCOPIC PROBES. THE PROBES GAVE EITHER "NO DEVICE CONNECTED" OR "POOR CONNECTION" ERROR MESSAGES. DURING A PROCEDURE, EACH PROBE FAILED TO FUNCTION SUCCESSFULLY WITH TWO SEPARATE GENERATORS. IN ORDER TO SECURE THE ABLATION, THE CASE WAS COMPLETED WITH A DIFFERENT DEVICE; HOWEVER, THIS RESULTED IN AN INCREASE OF ONE HOUR AND 30 MINUTES OF GENERAL ANESTHESIA TIME. THIS EVENT MEETS THE CRITERIA A REPORTABLE ADVERSE EVENT; PATIENT SAFETY RISK DUE TO PROLONGED PROCEDURE GREATER THAN 30 MINUTES (EXTENDED SEDATION). IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11028624 ↗
  • MalfunctionDec 17, 2020Activation Problem; Activation Problem

    FIRST REPORTED HABIB PROBE: AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH 4 HABIB 4X LAPAROSCOPIC PROBES. THE PROBES GAVE EITHER "NO DEVICE CONNECTED" OR "POOR CONNECTION" ERROR MESSAGES. DURING A PROCEDURE, EACH PROBE FAILED TO FUNCTION SUCCESSFULLY WITH TWO SEPARATE GENERATORS. IN ORDER TO SECURE THE ABLATION, THE CASE WAS COMPLETED WITH A DIFFERENT DEVICE; HOWEVER, THIS RESULTED IN AN INCREASE OF ONE HOUR AND 30 MINUTES OF GENERAL ANESTHESIA TIME. THIS EVENT MEETS THE CRITERIA A REPORTABLE ADVERSE EVENT; PATIENT SAFETY RISK DUE TO PROLONGED PROCEDURE GREATER THAN 30 MINUTES (EXTENDED SEDATION). IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11028579 ↗

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