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ClickClean™ UL330Recalls & reported problems

Medeon Biodesign, Inc. · The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids. · Class 2

Data updated Oct 16, 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 04719872920182), received between Aug 8, 2019 and Oct 3, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Insufficient Device Problem Information2

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IN ONE OF THE CLICKCLEAN CLINICAL USE, THE LOWER PART OF THE SCREEN IS BLOCKED AND MORE THAN 6 CLICKS CANNOT CLEAR THE VIEW: THE BLOCKAGE HAPPENED FROM THE BEGINNING OF THE CASE, NOT DURING THE CASE. THE BLOCKAGE LOOKED "CLOUDY" AND "BLURRY" AND USER CAN SEE THE OBJECTS VAGUELY, JUST AS SEE THROUGH FOG. AT THE BEGINNING OF THE 1ST CLICKCLEAN USE, THE BLURRY ACCOUNT FOR 25% OF THE LOWER-LEFT CORNER OF THE SCREEN. THE NURSE CLEANED THE SCOPE BY A SURGICAL SPONGE BEFORE INSERTING THE SCOPE TO 2ND CLICKCLEAN. THE BLOCKAGE ON THE 2ND CLICKCLEAN IS AROUND 10%-15% NEAR THE BOTTOM LEFT EDGE OF THE SCREEN. THE TOTAL PROCEDURE DELAY DUE TO CLICKCLEAN SWAP IS AROUND 3-5MIN. THE USER USED THE 2ND CLICKCLEAN TO THROUGHOUT THE REST OF THE SURGICAL PROCEDURE. THE TWO DEVICES WERE NOT ABLE TO BE RETURNED AND NOT ABLE TO VERIFY IF THE DEVICE OR SCOPE CAUSE THE IMAGE BLACKAGE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9149536 ↗
  • MalfunctionAug 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    DURING A PROCEDURE THE DOCTOR ATTEMPTED TO USE THE CLICKCLEAN AND THE LOWER LEFT PART WAS BLOCKED. SHE TRIED TO CLEAR IT SEVERAL TIMES AND WAS UNSUCCESSFUL. THE ANESTHESIA TIME WAS EXTENDED BRIEFLY. THERE WAS NO HARM TO THE PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8875104 ↗

Other Laparoscope, General & Plastic Surgery devices

All Laparoscope, General & Plastic Surgery devices →

Sources and updates

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