AESCULAP FB800RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04038653157907), received between Oct 29, 2021 and Oct 30, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED TO AESCULAP INC. THAT A TUFFIER RIB SPREADR170X12543X53MM BLDS (PART # FB800R) WAS USED DURING AN OPEN THORACOTOMY WITH DECORTICATION LEFT PROCEDURE ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT THE DEVICE WAS DIFFICULT TO OPEN AT FIRST BUT WAS ABLE TO BE UTILIZED DURING THE PROCEDURE. WHEN THE SURGEON ATTEMPTED TO REMOVE THE DEVICE, IT FROZE AND WOULD OT RELEASE OR ADJUST. REPORTEDLY THE SURGEON USED A NEEDLE DRIVE TO ATTEMPT TO OPEN THE INSTURMENT WHICH CAUSED THE BUTTERFLY ADJUSTMENT KNOB TO BREAK OFF. IN ORDER TO REMOVE THE EQUIPMENT THE PATIENT'S RIB WAS BROKEN. METAL SHAVINGS WERE OBSERVED ON THE STERILE TOWEL THAT THE INSTRUMENT WAS PLACED ON. POST OPERATION CHEST RADIOGRAPHY DID NOT RECEAL ANY METAL SHAVINGS INSIDE THE PATIENT. THE SURGERY WAS ABLE TO BE COMPLETED SUCCESSFULLY. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: Bone Fracture(s); Foreign Body In Patient

  MAUDE report 18029615 ↗
• InjuryOct 29, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  NO UPDATES REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12724475 ↗
• InjuryOct 29, 2021Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED TO AESCULAP (B)(4) THAT A TUFFIER RIB SPREADR170X12543X53MM BLDS (PART # FB800R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE COMPONENT OF THUMB SCREW, WHICH CONTROLS THE FUNCTION OF THE BLADES OPENING AND CLOSING, WAS MISSING. THE PATIENT UNDERWENT AN X-RAY TO CONFIRM IF PART HAD DETACHED AT THE SURGICAL SITE. THE SURGERY WAS DELAYED APPROXIMATELY TWENTY (20) MINUTES. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER (B)(4). INVOLVED COMPONENT FB800R-TUFFIER RIB SPREADR170X12543X53MM BLDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12724455 ↗