Arthrex® AR-3352-5501Recalls & reported problems
Arthrex, Inc. · 4K Laparoscope,0°,5.5x300mm, HI-MAG, NIR · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867346611), received between Nov 9, 2023 and Jul 11, 2024 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Defective Device” (4 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Device4
- Poor Quality Image3
- Display or Visual Feedback Problem2
- No Display/Image1
- Poor Visibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Insufficient Information3
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 11, 2024Poor Quality Image; Poor Quality Image
ON 06/18/2024 IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS(B)(4) THAT TWO (QTY.2) AR-3352-5501 SCOPES ARE PROVIDING CLOUDY IMAGES. CASE/PATIENT INVOLVEMENT NOT INDICATED.
Patient problems: Insufficient Information
MAUDE report 19718901 ↗MalfunctionJul 11, 2024Poor Quality Image; Poor Quality Image
ON (B)(6) 2024 IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT TWO (QTY.2) AR-3352-5501 SCOPES ARE PROVIDING CLOUDY IMAGES. CASE/PATIENT INVOLVEMENT NOT INDICATED.
Patient problems: Insufficient Information
MAUDE report 19718886 ↗MalfunctionJul 11, 2024Poor Quality Image; Poor Quality Image
ON 13 JUNE 2024 IT WAS REPORTED BY A SALES REP VIA EMAIL THAT AN AR-3352-5501 4K LAPAROSCOPE,0°,5.5X300MM, HI-MAG, NIR WAS REPORTED TO HAVE A BLURRY IMAGE BY THE CUSTOMER. THIS OCCURRED ON (B)(6) 2024 WITH NO CASE INVOLVEMENT INDICATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19718720 ↗MalfunctionJul 3, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
ON 06/07/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3352-5501 SCOPE'S LENS IS CLOUDY. NO CASE OR PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19667067 ↗MalfunctionJun 24, 2024Defective Device; Defective Device
ON (B)(6) 2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3352-5501 SCOPE HAS A DAMAGED TIP (QTY.3). THIS WAS DISCOVERED DURING AN ARTHROSCOPIC PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19593421 ↗MalfunctionJun 24, 2024Defective Device; Defective Device
ON 05/30/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3352-5501 SCOPE HAS A DAMAGED TIP (QTY.3). THIS WAS DISCOVERED DURING AN ARTHROSCOPIC PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19593335 ↗MalfunctionJun 24, 2024Defective Device; Defective Device
ON (B)(6) 2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3352-5501 SCOPE HAS A DAMAGED TIP (QTY.3). THIS WAS DISCOVERED DURING AN ARTHROSCOPIC PROCEDURE WITH NO PATIENT HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19593253 ↗MalfunctionMay 14, 2024Defective Device; Defective Device
ON 04/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4). THAT AN AR-3352-5501 SCOPE HAS A BLURRY LENS. ANOTHER SCOPE WAS USED TO COMPLETE THE CASE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19315918 ↗MalfunctionNov 9, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem
ON 10/12/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-3352-5501 LAPAROSCOPE AND AN AR-3352-5531 LAPAROSCOPES LENSES WERE BLURRY. THIS WAS DISCOVERED DURING A CASE, WITH NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18101448 ↗MalfunctionNov 9, 2023Poor Visibility; Poor Visibility
ON (B)(6) 2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-3352-5501 SCOPE HAD BLURRY VISION. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18101423 ↗MalfunctionNov 9, 2023No Display/Image; No Display/Image
ON 10/10/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-06054260 THAT AN AR-3352-5501 SCOPE HAD NO VISUAL. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18100725 ↗
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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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