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N/A 0794001010Recalls & reported problems

Stryker Corporation · SURGICAL TABLET · Class 1

Adverse event reports
7
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327509090), received between Apr 11, 2023 and Apr 12, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (7 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

Device problems

  • Incorrect Measurement7
  • Device Displays Incorrect Message1

Patient problems

  • No Clinical Signs, Symptoms or Conditions7

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 12, 2023Incorrect Measurement; Device Displays Incorrect Message; Incorrect Measurement; Device Displays Incorrect Message

    PER THE CUSTOMER, ONLY 4 OUT OF THE 9 SPONGES SCANNED OUT ON THE TABLET. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16725658 ↗
  • MalfunctionApr 12, 2023Incorrect Measurement; Incorrect Measurement

    PER URT CASE THE RFID SPONGE EW0G-GGNC-5DB3 GOT SCANNED IN WITH A DIFFERENT PACK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16722934 ↗
  • MalfunctionApr 11, 2023Incorrect Measurement; Incorrect Measurement

    PER A REVIEW OF A URT CASE IT WAS FOUND THE DEVICE WAS SCANNED IN WITH ANOTHER PACK . THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16720386 ↗
  • MalfunctionApr 11, 2023Incorrect Measurement; Incorrect Measurement

    PER THE CUSTOMER, THE DEVICE WAS SCANNED IN WITH ANOTHER PACK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16720379 ↗
  • MalfunctionApr 11, 2023Incorrect Measurement; Incorrect Measurement

    PER THE URT CASE THE DEVICE WAS SCANNED IN WITH ANOTHER PACK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16720377 ↗
  • MalfunctionApr 11, 2023Incorrect Measurement; Incorrect Measurement

    PER A REVIEW OF THE URT DATABASE THE DEVICE WAS SCANNED IN WITH ANOTHER PACK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16720374 ↗
  • MalfunctionApr 11, 2023Incorrect Measurement; Incorrect Measurement

    PER THE URT CASE THE DEVICE WAS SCANNED IN WITH ANOTHER PACK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16720368 ↗

Other Counter, sponge, surgical devices

All Counter, sponge, surgical devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.