Innomed, Inc. 1790-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840277102034), received between Oct 23, 2015 and Oct 23, 2015 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

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

• MalfunctionOct 23, 2015Break

  AN ADVERSE REPORT WAS SUBMITTED REGARDING INNOMED PART NUMBER 1790-02. THE REPORTER CLASSIFIED THE EVENT AS A MALFUNCTION, AND ACCORDING TO THE REPORT, THE RONGEUR BROKE INTRAOPERATIVELY INTO TWO PIECES. THE PIECES WERE SEGREGATED AND NO INJURIES WERE SUSTAINED BY THE PATIENT. THE REPORT CONTAINED NO CONTACT INFORMATION, NOR WAS THE LOCATION OF THE EVENT PROVIDED. NO INFORMATION DESCRIBING THE EVENT HAS BEEN FORWARDED TO INNOMED BY THE REPORTER, AND THE DEVICE HAS NOT BEEN RETURNED FOR AN EVALUATION. THIS REPORT WAS DISCOVERED BY PERFORMING AN INTERNAL MONTHLY SURVEY OF MAUDE. INNOMED IN UNABLE TO PERFORM A THOROUGH INVESTIGATION BECAUSE THE INFORMATION PROVIDED BY THE REPORTER IS LIMITED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5171573 ↗