LAPAROSCOPIC TUBING 2390JRecalls & reported problems
Megadyne Medical Products, Inc. · Megadyne Laparoscopic Tubing · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10614559104590), received between Nov 11, 2021 and Apr 18, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product1
- Difficult or Delayed Activation1
- Misassembled1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT BEFORE AN UNKNOWN SURGERY, THE STERILE PACKAGE HAD BEEN ALREADY OPENED BEFORE THE PRODUCT WAS NOT USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19137616 ↗MalfunctionNov 11, 2021Misassembled; Difficult or Delayed Activation; Misassembled; Difficult or Delayed Activation
IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, AIR LEAK OCCURRED FROM BETWEEN TROCAR AND THE TIP OF THE EVACUATION TUBE. THE ISSUE OCCURRED 1 HOUR AFTER THE OPERATION WAS STARTED. THE DEVICE WAS USED ON THE LAPAROSCOPIC MODE. THE SURGEON COMMENTED THAT THE SUCTION SEEMS TO BE NOT STOPPED. THE TROCAR WAS LOOSE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12797612 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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