Symmetry Tuffier 54-2242Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887482079379), received between Sep 29, 2015 and Jul 23, 2018 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2018Break

  RETRACTOR BROKE WHILE IN A CASE, NO PATIENT INJURY/INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7712908 ↗
• MalfunctionSep 29, 2015Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  THE SURGEON MADE AN INCISION ALONG THE POSTERIOR AXILLARY LINE, APPROX THE FIFTH INTERSPACE CARRIED DOWN THROUGH VARIOUS LAYERS WITH ELECTROCAUTERY. THE LUNG WAS DEFLATED AND THE CHEST WAS ENTERED. THE SCOPE WAS PLACED. ADHESION WAS BROKEN UP WITH THORASCOPE. THE SCOPE WAS THEN REMOVED. THE INCISION WAS OPENED TO A THORACOTOMY. PARTIAL PLEURECTOMY AND TOTAL DECORTICATION WAS PERFORMED. BRONCHOPLEURAL (BP) FISTULA WAS WEDGED WITH ENDO-DIA STAPLING DEVICE. TUFFIER RETRACTOR WAS IN THE LEFT CHEST. TO DETRACT INCISION AND REMOVE TUFFIER, THE KNOB NEEDED TO TURN AND RETRACTOR BROKE OFF. THE SURGEON HAD TO EXTEND THE INCISION TO REMOVE THE IRRIGATED WITH COPIOUS AMOUNTS OF ANTIBIOTIC SOLUTION. TWO CHEST TUBES WERE PLACED. THE PT TOLERATED THE PROCEDURE WELL AND WEN TO CV INTENSIVE C.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5127970 ↗