Trivex System 7210387FRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840663107391), received between Aug 9, 2018 and Feb 14, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Conduct” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K032387); they may or may not involve this specific model.

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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  DURING PRE-USE CHECK, THE HANDPIECE FAILED TO OPERATE PROPERLY. THE BLADE ROTATED INTERMITTENTLY EVEN WHEN THE RUN BUTTON WAS NOT PRESSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9714615 ↗
• MalfunctionNov 9, 2018Failure to Conduct; Failure to Conduct

  DURING PRE-USE CHECK, THE RESECTOR ON THE HANDPIECE DID NOT ROTATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8056680 ↗
• MalfunctionNov 9, 2018Failure to Conduct; Failure to Conduct

  DURING PRE-USE CHECK, THE RESECTOR ON THE HANDPIECE DID NOT ROTATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8056675 ↗
• MalfunctionNov 5, 2018Failure to Conduct; Failure to Conduct

  DURING PRE-USE CHECK, THE RESECTOR ON THE HANDPIECE DID NOT ROTATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8039697 ↗
• MalfunctionNov 1, 2018Failure to Conduct; Failure to Conduct

  DURING PRE-USE CHECK, THE RESECTOR ON THE HANDPIECE DID NOT SPIN AT ALL WHEN PRESSING EITHER THE RUN OR THE WINDOW LOCK BUTTON.

  Patient problems: No Information

  MAUDE report 8030752 ↗
• MalfunctionAug 9, 2018Failure to Conduct; Electrical /Electronic Property Problem; Failure to Conduct; Electrical /Electronic Property Problem

  DURING PRE-USE CHECK, THE BLADES OF THE RESECTOR DID NOT SPIN.

  Patient problems: No Information

  MAUDE report 7769047 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032387. One submission often covers many models, so check the product and lot details in each record.

• Z-1105-2007 · Oct 12, 2004 · Terminated
  Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc. - Endoscopy, Andover, MA 01810.