Arthrex® AR-3290-0001Recalls & reported problems
Arthrex, Inc. · SYNERGY INSUF(ENGL ,GERM,FRENCH,SPANISH) · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867100817), received between Sep 2, 2020 and May 1, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Defective Device1
Patient problems
- Arrhythmia1
- Cyanosis1
- Low Oxygen Saturation1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2024Defective Device; Defective Device
IT WAS REPORTED THAT THE AR-3290-0001 IS SHOWING A CONTAMINATION ERROR ON THE SCREEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19219613 ↗InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY ON (B)(6) 2020. DURING THIS PROCEDURE, THE ANAESTHETIST NOTED THAT CO2 PRESSURES HAD DROPPED SIGNIFICANTLY AND THE PATIENT'S O2 SATURATIONS HAD ALSO DROPPED. CARDIAC ARRHYTHMIA WAS THEN NOTED ON ECG; POSSIBLE VF. EMERGENCY/MET CALL WAS INITIATED AND THE PATIENT'S HEAD WAS MOVED DOWN IN LITHOTOMY POSITION. THE DRAPES WERE PULLED BACK AND THE PATIENT CYANOSED. PATIENT ASYSTOLE. THE OPERATING TABLE WAS LEVELED OUT AND CPR COMMENCED. CPR PERFORMED FOR 10 SECONDS BEFORE PATIENT REVERTED BACK TO SINUS RHYTHM. ANAESTHETIC GASES WERE TURNED OFF; 100% O2 AND INTRAVENOUS ANAESTHETIC SOLELY USED. ANAESTHETIST INFORMED HOSPITAL INTENSIVIST, TO REVIEW PATIENT IN RECOVERY. SURGERY WAS OK TO CONTINUE AS PATIENT WAS NOW STABLE. INTENSIVIST REVIEWED, TO GO TO HDU POST OP AND CARDIAC REVIEW/INVESTIGATION. AT TIME OF EVENT, THE SURGEON HAD PERFORMED THE LAPAROSCOPIC PART OF THE PROCEDURE AND WAS REMOVING THE UTERUS VAGINALLY. NO CO2 GASES (LAPAROSCOPIC INSUFFLATION) WERE ON AT THE TIME. THE PRESSURE WAS SET AT 15 ABD THE FLOW WAS- HIGH FLOW ¿ SET AT 20. GAS WAS TURNED OFF AT TIME OF INCIDENT. ADDITIONAL INFORMATION
Patient problems: Arrhythmia; Cyanosis; Low Oxygen Saturation; No Code Available
MAUDE report 10484032 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.