Synergy Insufflation FM134Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04056702002824), received between Sep 17, 2020 and Feb 14, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “High Readings” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2022Noise, Audible

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3290-0004 WAS NOT HOLDING PRESSURE, AND WAS MAKING CONTINUOUS CLICKING NOISES. THE CASE WAS DELAYED AN HOUR. THE PATIENT WAS NOT EFFECTED. ADDITIONAL INFORMATION 02/08/2022: ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3290-0004 INSUFFLATOR DOES HOLD PRESSURE AND CONTINUES TO MAKE CLICKING NOISES. WHEN HOOKED TO THE OPERATIVE CANNULAS THE PRESSURE WOULD DROP TO ZERO AND FLUID WOULD BACKFILL. THE CASE WAS DELAYED AN HOUR, EXTRA ANESTHESIA WAS NEEDED. THIS WAS DISCOVERED DURING USE IN A LAP CHOLE PROCEDURE ON (B)(6) 2022.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13529189 ↗
• InjuryJun 28, 2021Intermittent Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT WHEN THE AR-3290-0004 SYNERGY INSUFFLATOR STOPS INSTILLING GAS AND RESUMES, THE FLOW GOES UP TOO MUCH EVEN THOUGH NOT INTENDED RESULTING IN PATIENT¿S ABDOMEN IS SWOLLEN TOO MUCH. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Swelling/ Edema

  MAUDE report 12075640 ↗
• InjurySep 17, 2020High Readings

  IT WAS REPORTED THE FACILITY HAS HAD THREE PATIENTS SHOWING HIGH CARBON DIOXIDE LEVELS. THEY ARE NOT CERTAIN THAT THE INSUFFLATOR IS CAUSING THE PROBLEM, BUT THEY WANT TO EXCHANGE THE DEVICE. ADDITIONAL INFORMATION OBTAINED 9/17/20: THE FACILITY REPORTER STATES THAT OVER A 2 TO 3 WEEK PERIOD IT WAS DISCOVERED ACROSS DIFFERENT ANESTHESIOLOGIST THAT THERE WERE 3 CASES OF HIGHER THAN NORMAL CO2 LEVELS MEASURE ON THE ANESTHESIA MACHINE. SINCE THE INCIDENTS WERE RANDOM, OVER A FEW WEEKS TIME AND WITH SEVERAL DIFFERENT DOCTORS IT WAS NOT DISCOVERED RIGHT AWAY THAT THERE MAY BE AN ISSUE. THERE WERE NO PATIENT INJURIES OR DEATH. SPECIFIC CASE DETAILS WERE NOT NOTED AND ARE NOT AVAILABLE TO PROVIDE. THE ANESTHESIA MACHINE WAS REMOVED FROM SERVICE FOR MAINTENANCE AND CALIBRATIONS. THE INSUFFLATOR, OUT OF AN ABUNDANCE OF CAUTION WAS ALSO REMOVED FROM THE ROOM AND WAS BEING SENT BACK TO ARTHREX FOR EXCHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10548996 ↗