Arthrex® AR-3351-1031Recalls & reported problems
Arthrex, Inc. · 4K Laparoscope, 30°, 10x330mm, NIR · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867161122), received between Oct 26, 2023 and Jul 11, 2024 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (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.
Reports received per month
Most reported problems
Device problems
- Poor Quality Image2
- Fogging1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
- Liver Laceration(s)1
Recent adverse event reports
The 4 most recent of 4 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 (B)(4) THAT AN AR-3351-1031 SCOPE HAS AN INABILITY TO EFFECTIVELY FOCUS THE IMAGE. CASE/PATIENT INVOLVEMENT NOT INDICATED.
Patient problems: Insufficient Information
MAUDE report 19718862 ↗MalfunctionMay 3, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE DEVICE HAS A BAD IMAGE QUALITY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED. ***UPDATE AHA FROM 16-APR-2024 THE PROBLEM WAS NOTICED DURING THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19239306 ↗InjuryMar 11, 2024Fogging; Fogging
IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY EXCESSIVE FOGGING WAS NOTICED ON THE SCOPE. THE SURGEON DECIDED TO CONTINUE TO THE SURGERY WITH THE DEVICE. DURING THE SURGERY HOWEVER DUE TO OBSTRUCTED VIEW THE SURGEON CAUSED A LACERATION TO THE LIVER DUE TO THE FOGGING. THE PATIENT WAS KEPT OVERNIGHT TO BE MONITORED BUT NO FURTHER TREATMENT WAS REPORTED.
Patient problems: Liver Laceration(s)
MAUDE report 18877391 ↗MalfunctionOct 26, 2023Material Separation; Material Separation
IT WAS REPORTED THAT THE EYEPIECE OF THE LAPAROSCOPE IS BROKEN OFF. IT WAS NOTICED AFTER THE SURGERY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18011800 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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