NA 72203994Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010673497), received between May 4, 2018 and Apr 26, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2021Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT DURING USE IN A BI-LATERAL INGUINAL HERNIA REPAIR USING THE SMITH & NEPHEW 500 INSUFFLATOR RESULTED IN A OVER GASSING OF THE PATIENT. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11725555 ↗
• MalfunctionApr 9, 2019Inflation Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE OVER-INFLATE, THE PRESSURE WENT ABOVE SETTING. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8496266 ↗
• MalfunctionMay 4, 2018Failure to Cut; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE DEVICE DID NOT CUT OFF AFTER SET PRESSURE WAS REACHED. THE MACHINE CONTINUOUSLY PUMPED GAS IRRESPECTIVE OF PRESSURE, DUE TO WHICH THE ABDOMEN PRESSURE WENT EXTREMELY HIGH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7489003 ↗
• MalfunctionMay 4, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DR. HAD CONNECTED MACHINE TO THE PATIENT AND STARTED SURGERY BY CREATING PNEUMOPERITONEUM WITH THE INSUFFLATOR. AFTER SOME TIME THEY NOTICED THAT THE PATIENT'S PRESSURE HAD INCREASED VERY HIGH AND ALSO NOTICED BLEEDING FROM PERITONEAL LAYER. WHEN THEY LOOKED AT THE INSUFFLATOR PRESSURE, IT WAS SHOWING 12 MMHG ACTUAL PRESSURE AS SAME AS SET PRESSURE BUT GAS WAS FLOWING CONTINUOUSLY. IMMEDIATELY THEY STOPPED FLOW AND WITH GREAT EFFORT THEY STOPPED BLEEDING. THEY FINISHED SURGERY WITH STANDBY MACHINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension

  MAUDE report 7488996 ↗