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TA Premium 010460Recalls & reported problems

Covidien LP · Reusable Stapler · Class 1

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 10884521048997), received between Nov 6, 2018 and Nov 6, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Align” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Failure to Align1
  • Failure to Form Staple1

Patient problems

  • No Code Available1

Recent adverse event reports

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

  • InjuryNov 6, 2018Failure to Align; Failure to Form Staple; Failure to Align; Failure to Form Staple

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT OPEN HEMICOLECTOMY PROCEDURE, WHILE TRANSECTING THE RIGHT COLON, THE TIP OF THE INSTRUMENT DID NOT SEEM TO BE ALIGNING PROPERLY AND THE STAPLE LINE DIDN'T FEEL CORRECT WHEN FIRING OR LOOK CORRECT POST FIRING. THE STAPLE LINE WAS RESECTED AND RE-STAPLED TO RESOLVE THE ISSUE. THE SURGEON HAD TO FREE UP MORE BOWEL TO REDO THE ANASTOMOSIS EXTENDING THE PROCEDURE BY 45 MINUTES.

    Patient problems: No Code Available

    MAUDE report 8042391 ↗

Other APPARATUS, SUTURING, STOMACH AND INTESTINAL devices

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