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Arthrex® AR-9808SJ-45Recalls & reported problems

Arthrex, Inc. · COOLCUT 45, BALL ELECTRODE, SJ · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867062764), received between Aug 17, 2020 and Aug 17, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Deliver Energy” (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 16, 2026.

Most reported problems

Device problems

  • Failure to Deliver Energy1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 17, 2020Failure to Deliver Energy

    IT WAS REPORTED THAT DURING A TFCC (TRIANGULAR FIBROCARTILAGE COMPLEX) DEBRIDEMENT THE SURGEON ATTEMPTED TO USE TWO ARTHREX COOLCUT WANDS, AR-9808SJ-45 (LOT 1909099). BOTH WANDS WOULD NOT CREATE ENERGY AT 15/15 CUT AND COAG. THE PATIENT WAS GROUNDED AND LR SALINE WAS USED. AFTER THE ISSUE OCCURRED THE SURGEON OPTED TO DO A REPAIR AND MADE A SMALL INCISION AND USED A STANDARD DEVICE FROM ANOTHER MANUFACTURER WITHOUT ISSUE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10417088 ↗

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Sources and updates

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