Symmetry Bookwalter® 50-4580Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887482018545), received between Jun 16, 2023 and Aug 22, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionAug 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE CUSTOMER ALLEGED THAT THE BOOKWALTER HORIZONTAL FLEX BAR BECAME LOOSE CAUSING IT TO FALL INTO THE PATIENT'S ABDOMEN. THERE WAS NO HARM TO THE PATIENT. A DELAY IN THE PROCEDURE OCCURRED TO CORRECT THE PLACEMENT OF THE DEVICES. THE LENGTH OF THE DELAY IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596456 ↗
• MalfunctionJun 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER ALLEGED THAT DURING A PANCREATIC TRANSPLANT, THE CLIP OF THE BOOKWALTER RATCHET WOULD NOT SECURE PROPERLY TO THE RING. UPON FURTHER INSPECTION OF THE RATCHET, IT WAS NOTICED THAT A SMALL SCREW WAS MISSING. THIS OCCURRED AT THE FIRST USE OF THE DEVICE DURING THE PROCEDURE, SO IT IS UNKNOWN IF THE SCREW FELL OUT DURING THAT PROCEDURE OR PREVIOUSLY. THERE WAS NO AFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148576 ↗