Swann Morton Ltd. ASR BULK No. 15T STAINLESS BLADESRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05033955183929), received between Jan 21, 2022 and Jan 21, 2022 — 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.

• MalfunctionJan 21, 2022Break

  THE CUSTOMER REPORTED THAT DURING THE SURGICAL PROCEDURE, THE BLADE FROM THE SCALPEL BROKE IN HALF INSIDE THE PATIENT'S KNEE. A LARGER INCISION NEEDED TO BE MADE TO REMOVE THE BROKEN PIECE. THE BROKEN BLADE WAS REMOVED IN ONE PIECE AND PER PROTOCOL, AN XRAY WAS TAKEN TO VERIFY THERE WAS NO PRODUCT LEFT BEHIND. THERE WAS NO HARM TO THE PATIENT OR STAFF DUE TO THIS BROKEN SCALPEL BLADE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13319091 ↗