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Medline Industries, Inc. DYNJ35353FRecalls & reported problems

Medline Industries, Inc. · LAP CHOLE PACK · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888277744264), received between Aug 8, 2022 and Aug 8, 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

Device problems

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionAug 8, 2022Break

    PT HERE FOR A LAP CHOLE, WHILE AFTER THE TROCAR WAS INSERTED THE SYRINGE THAT IS USED IN INFLATE THE BALLOON BROKE. THE TROCAR AND SYRINGE WAS SEQUESTERED AND GIVEN TO ME THE DIRECTOR. A SECOND TROCAR WAS USED AND THE PROCEDURE CONTINUED AS SCHEDULED. SYSTEM SENT MATERIALS MANAGEMENT FOR RETURN TO VENDOR

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15182469 ↗

Other laparoscopy kit devices

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Sources and updates

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