ISOLA 205197Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034001708), received between Jun 27, 2022 and Jun 27, 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.

• MalfunctionJun 27, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: WE HAVE HAD TO RAISE A DSI AND PRODUCT COMPLAINT FOR INSTRUMENT 205197 THAT WAS IN AN LOAN KIT USISO01N, LOT 1 HOWEVER WAS BROKEN. THIS MEANT THE KIT COULD NOT BE USED FOR THE OPERATION AND AN ALTERNATIVE METHOD WAS USED. THE KITS WERE CHECKED AND THE PART IN QUESTION IS AN OBSOLETE PART. THIS FAULTY PART WILL BE TAKEN OUT OF THE KIT BUT THERE IS NO REPLACEMENT STOCK AVAILABLE DUE TO ITS OBSOLESCENCE. THE KIT WILL BE CLOSED UNTIL THE TEMPLATE IS CHECKED AND CORRECTED. THIS REPORT IS FOR ONE (1) PI CABLE/WIRE S/DRV. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14828427 ↗