ISPAN 8065797303Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00380657973033), received between Mar 2, 2021 and Dec 3, 2024 — classified as 56 malfunctions.

The most frequently reported specific device problem is “Gas Output Problem” (41 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2024Gas Output Problem; Gas Output Problem

  A NURSE REPORTED THAT PRIOR TO SURGERY, THE OPHTHALMIC REGULATOR COULD NOT BE USED BECAUSE THE O-RING DID NOT STAY IN PLACE, WHICH STOPPED THE GAS FROM PASSING THROUGH. THE SURGERY WAS COMPLETED USING AN ALTERNATIVE REGULATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20829263 ↗
• MalfunctionSep 26, 2024Gas/Air Leak; Gas/Air Leak

  A NURSE REPORTED THAT BEFORE VITRECTOMY SURGERY, GAS LEAKAGE WAS FOUND EVEN AFTER TURNING OFF THE SWITCH AND KNOB OF THE PRESSURE REDUCING VALVE. THE SURGERY WAS COMPLETED, AND THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20307980 ↗
• MalfunctionSep 26, 2024Gas/Air Leak; Gas/Air Leak

  A NURSE REPORTED THAT BEFORE VITRECTOMY SURGERY, GAS LEAKAGE WAS FOUND EVEN AFTER TURNING OFF THE SWITCH AND KNOB OF THE PRESSURE REDUCING VALVE. THE SURGERY WAS COMPLETED AND THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20307962 ↗
• MalfunctionAug 15, 2024Gas Output Problem; Gas Output Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC REGULATOR DID NOT FUNCTION AS EXPECTED WHEN DRAWING UP THE GAS INTO THE SYRINGE DURING VITRECTOMY WITH RETINAL DETACHMENT SURGERY. IT WAS ALSO REPORTED THAT WHEN THE SURGEON USED THE GASES, COULD NOT PUSH THE GAS IN TO THE SMALL VOLUME SYRINGE AND WHEN USED A LARGER VOLUME SYRINGE IT WAS VERY SLOW TO FILL BUT COULD BE IMPROVED BY BREAKING THE SEAL/PULLING BACK ON THE PLUNGER. THE SURGERY WAS COMPLETED ON THE SAME DAY WHEN OLD REGULATORS PUT ON THE TANK, THE PROBLEM WAS GREATLY IMPROVED ON ALL SIZE SYRINGES. THE PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19991189 ↗
• MalfunctionJul 2, 2024Gas Output Problem; Gas Output Problem

  A NURSE REPORTED THAT NO GAS CAME OUT OF REGULATOR DURING SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM. DETAILS OF SURGERY WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660798 ↗
• MalfunctionJun 28, 2024Gas Output Problem; Gas Output Problem

  A NURSE REPORTED THAT AN OPHTHALMIC GAS CYLINDER WAS NOT ALLOWING GAS TO COME. DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL DETAILS HAD BEEN REQUESTED AND NONE RECEIVED TILL DATE. ADDITIONAL INFORMATION RECEIVED REPORTING THAT DURING SURGERY AN OPHTHALMIC GAS CYLINDER WAS NOT ALLOWING GAS TO COME. THERE WAS NO PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 19631870 ↗
• MalfunctionMay 27, 2024Gas Output Problem; Gas Output Problem

  A CUSTOMER REPORTED THAT THE OPHTHALMIC CONSOLE GAS REGULATOR CLOGGED. THEY REMOVED THE REGULATOR AND UTILIZED A SECOND ONE FOR USE. THERE HAS BEEN NO PATIENT PRESENT DURING THE SETUP FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19401126 ↗
• MalfunctionMay 21, 2024Gas Output Problem; Gas Output Problem

  A CUSTOMER REPORTED THAT AN OPHTHALMIC REGULATOR WAS SLOW TO DISPENSE GAS BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED WITH THE SAME PRODUCT. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19357656 ↗
• MalfunctionMay 20, 2024Gas Output Problem; Gas Output Problem

  A NURSE REPORTED THAT BEFORE VITRECTOMY SURGERY, AN OPHTHALMIC GAS REGULATOR WAS UNABLE TO RELEASE GAS. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEW DEVICE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19349867 ↗
• MalfunctionApr 11, 2024Gas Output Problem; Gas Output Problem

  A CUSTOMER REPORTED THAT AN OPHTHALMIC REGULATOR NOT DISPENSING GAS AT ALL. DETAILS OF PROCEDURE WAS NOT REPORTED. THERE WAS NO PATIENT HARM. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE. ADDITIONAL INFORMATION RECEIVED REPORTING THAT DURING VITRECTOMY SURGERY THE OPHTHALMIC REGULATOR WAS NOT DISPENSING GAS AT ALL. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087857 ↗
• MalfunctionApr 3, 2024Gas Output Problem; Gas Output Problem

  A CUSTOMER REPORTED THAT AN OPHTHALMIC REGULATOR WAS NOT DISPENSING GAS. DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE. ADDITIONAL INFORMATION RECEIVED REPORTING THAT SCHEDULED PROCEDURE WAS VITRECTOMY SURGERY AND THE EVENT HAPPENED DURING SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19033440 ↗
• MalfunctionFeb 26, 2024Gas Output Problem; Gas Output Problem

  A CUSTOMER REPORTED THAT FROM AN OPHTHALMIC REGULATOR THE GAS WAS NOT DISPENSED AFTER ALL TROUBLE SHOOTING ATTEMPTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER REGULATOR. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18776350 ↗
• MalfunctionFeb 6, 2024Gas Output Problem; Gas Output Problem

  A NURSE REPORTED THAT AN OPHTHALMIC GAS DISPENSING REGULATOR VALVE CANNOT RELEASE GAS DURING USE. THE PROCEDURE DETAILS AND PATIENT IMPACT DETAILS HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18651736 ↗
• MalfunctionJan 22, 2024Gas Output Problem; Gas Output Problem

  A CUSTOMER REPORTED THAT THE GAS WAS NOT EMITTED FROM AN OPHTHALMIC REGULATOR AFTER OPENING THE SCREW KNOBS. THE PROCEDURE DETAILS AND PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18551004 ↗
• MalfunctionJan 10, 2024Gas Output Problem; Gas Output Problem

  A CUSTOMER REPORTED THAT AN OPHTHALMIC OPERATING REGULATOR WOULD NOT DISPENSE THE GAS. THE PROCEDURE AND PATIENT HARM DETAILS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18483194 ↗
• MalfunctionJan 2, 2024Gas Output Problem; Gas Output Problem

  A CUSTOMER REPORTED THAT DURING A SETUP OF PARS PLANA VITRECTOMY SURGERY, REGULATOR FAILED TO DISPENSE AN OPHTHALMIC GAS FREQUENTLY. PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18424967 ↗
• MalfunctionOct 11, 2023Defective Device; Defective Device

  A CUSTOMER REPORTED THAT BEFORE THE VITRECTOMY SURGERY, OPHTHALMIC GAS TANK REGULATOR WAS NOT DISPENSING THE GAS. SURGERY WAS COMPLETED BY CHANGING THE GAS TANK. THERE WAS NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17910851 ↗
• MalfunctionSep 25, 2023Gas Output Problem; Gas Output Problem

  A CUSTOMER REPORTED THAT AN OPHTHALMIC GAS CYLINDER REGULATOR WAS NOT WORKING. THE OPERATING STAFF CAN HEAR THE GAS BUT NOT FLOWING THROUGH THE OPHTHALMIC REGULATOR. A NEW REGULATOR WAS APPLIED TO THE CYLINDER AND THAT WORKED FINE. THE DETAILS OF PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807017 ↗
• MalfunctionSep 25, 2023No Flow; No Flow

  ADDITIONAL INFORMATION RECEIVED SCHEDULED PROCEDURE WAS CATARACT AND VITRECTOMY COMBINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17806699 ↗
• MalfunctionSep 17, 2023Gas Output Problem; Gas Output Problem

  A CUSTOMER REPORTED DURING A VIT RETINAL SURGERY THAT WHEN THE USER ATTEMPTED TO DISPENSE THE GAS IT WOULD NOT COME OUT AT ALL FROM AN OPHTHALMIC REGULATOR. THE PROCEDURE WAS PAUSED AND USED ANOTHER FREE-STANDING REGULATOR TO COMPLETE. NO PATIENT HARM OR IMPACT AS A NEW REGULATOR WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17762242 ↗
• MalfunctionAug 30, 2023No Flow; No Flow

  A CUSTOMER REPORTED THAT OPHTHALMIC GAS TANK VALVE NOT MEASURING THE VOLUME CONTAINED AND NOT RELEASING THE GAS FOR USE, EVEN WITH A FULL TORPEDO. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17650876 ↗
• MalfunctionAug 7, 2023Gas Output Problem; Gas Output Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE ISSUE OF THE GAS NOT DECANTING PROPERLY HAS BEEN FOR AN EXTENDED PERIOD OF TIME WITH NUMEROUS PATIENTS. ALL SURGERIES WERE ABLE TO BE COMPLETED WITHOUT INCIDENT, EITHER BY WAITING FOR A VERY LONG TIME FOR THE SF6 TO FLOW, OR BY SURGEON CHANGING TO DIFFERENT GAS. ALL PROCEDURES WERE RETINAL VITRECTOMIES. NO SYSTEM USED TO GIVE MESSAGE OR WARNING. NO PATIENT HARM OR SURGICAL COMPLICATION, SIMPLY DELAYED PROCEDURE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469057 ↗
• MalfunctionJul 31, 2023Gas Output Problem; Gas Output Problem

  A NURSE REPORTED THAT BEFORE A VITREO-RETINAL SURGERY AN OPHTHALMIC REGULATOR DID NOT DISPENSE GAS. PROCEDURE WAS COMPLETED ON THE SAME DAY WITH ANOTHER REGULATOR. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17423460 ↗
• MalfunctionJul 20, 2023Gas Output Problem; Gas Output Problem

  A CUSTOMER REPORTED THAT AN OPHTHALMIC REGULATOR WOULD NOT WORK AND IT WAS NOT DISPENSED THE GAS. THE PROCEDURE AND PATIENT HARM DETAILS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE. ADDITIONAL INFORMATION RECEIVED THAT SURGERY WAS COMPLETED BY USING THE ALTERNATIVE REGULATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17362354 ↗
• MalfunctionJul 20, 2023Gas Output Problem; Gas Output Problem

  A CUSTOMER REPORTED THAT AN OPHTHALMIC REGULATOR WOULD NOT WORK AND IT WAS NOT DISPENSED THE GAS. THE PROCEDURE AND PATIENT HARM DETAILS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE. ADDITIONAL INFORMATION RECEIVED THAT SURGERY WAS COMPLETED BY USING THE ALTERNATIVE REGULATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17362353 ↗