Engauge 8065751577Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380657515776), received between Mar 18, 2021 and Nov 18, 2025 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 5, 2025Open, Classified

   Due to incomplete seals in the pouch which provide the sterile barrier.

   Z-0305-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Dull, Blunt; Dull, Blunt

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE TIP OF TROCAR WAS CHIPPED AT UNKNOWN TIMING. THE PROCEDURE TYPE AND COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23579806 ↗
• MalfunctionAug 8, 2025Disconnection; Disconnection

  ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THAT THE ISSUE WAS RELATED TO A MISSING TROCAR HUB OR CANNULA, AND NOT BECAUSE THE TROCAR CANNULA WAS NOT ATTACHED TO THE TROCAR BLADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22747319 ↗
• MalfunctionJun 26, 2024Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT CUTTING OF THE TROCAR WAS POOR DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613388 ↗
• MalfunctionMay 10, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  A PHYSICIAN REPORTED THAT TIP OF CHANDELIER WAS COARSE DURING CATARACT/VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19287713 ↗
• MalfunctionJun 30, 2023Disconnection; Difficult to Remove; Disconnection; Difficult to Remove

  A PHYSICIAN REPORTED THAT THE SHAFT OF TROCAR (CYLINDRICAL PART) WAS MISSING. TROCAR WAS PULLED OUT WITH THE CHANDELIER, AND THE SHAFT PART OF THE TROCAR DISAPPEARED DURING THE PARS PLANAR VITRECTOMY (PPV) SURGERY. THE SHAFT PART WAS NOT FOUND, AND SURGEON CHECKED ALL OVER THE INSIDE OF THE EYE AND ON THE CONJUNCTIVA (THERE WAS NO PARTICULAR DISCOMFORT FOUND WHEN SUTURING). THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17235577 ↗
• MalfunctionApr 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN REPORTED THAT THE TROCAR CANNULA HUB WAS DETACHED FROM THE SHAFT DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16817101 ↗
• MalfunctionMar 21, 2023Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT THE TROCAR DID NOT PENETRATE THE TISSUE AT ALL AND HAD A POOR CUTTING DURING SURGERY. THE INVOLVED EYE AND THE PATIENT IDENTIFIER WERE NOT AVAILABLE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY BY REPLACING IT WITH OTHER PACK. THE PROCEDURE TYPE DETAIL WAS NOT REPORTED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583426 ↗
• InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED POSTOPERATIVE ENDOPHTHALMITIS DURING COMBINED VITRECTOMY FOR RETINAL DETACHMENT AND CATARACT SURGERY. THE EYE WAS ALREADY FOUND CLOUDY BY THE EXAM OF THE SLIT LAMP. THE PATIENT ALSO COMPLAINED OF EYE PAIN. INTRAOCULAR WASHING WAS PERFORMED. BACKFLUSH AND OTHER PRODUCTS OF OTHER COMPANIES ARE ALSO SUSPECTED TO BE INVOLVED. OTHER EQUIPMENT IN THE FACILITY WAS ALSO BEING INVESTIGATED. RISK OF DISABILITY WAS THE SURGEON'S ASSESSMENT.

  Patient problems: Blurred Vision; Endophthalmitis; Eye Pain

  MAUDE report 16067389 ↗
• InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THE PATIENT DEVELOPED ENDOPHTHALMITIS TWO DAYS AFTER THE EPIRETINAL MEMBRANE (ERM) AND CATARACT COMBINED SURGERY. THE PATIENT DEVELOPED INTRAOCULAR INFLAMMATION, THEREFORE INTRAOCULAR RINSING WAS PERFORMED, AND ANTIMICROBIAL AGENTS WERE ADMINISTERED. THE PATIENT'S EYE WAS CONFIRMED TO BE IMPROVING.

  Patient problems: Endophthalmitis; Inflammation

  MAUDE report 16066497 ↗
• MalfunctionJan 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN REPORTED THE SHAFT PART OF THE TROCAR CANNULA DISINTEGRATED AND WENT MISSING WHILE REMOVING THE TROCAR FROM THE EYE DURING A SURGERY. THE PRODUCT WAS REPLACED AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13167284 ↗
• MalfunctionOct 13, 2021Break; Break

  A PHYSICIAN REPORTED A TROCAR CANNULA PORT FROM THE CHANDELIER PACK BROKE DURING USAGE IN A PROCEDURE. THE PRODUCT WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12626032 ↗
• MalfunctionJun 7, 2021Material Separation; Material Separation

  A PHYSICIAN REPORTED TROCAR SHAFT WAS FOUND ON THE FIBER OF A CHANDELIER WHILE REMOVING IT FROM A TROCAR AT THE END OF THE PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11947037 ↗
• MalfunctionMar 19, 2021Break; Break

  THE CUSTOMER REPORTED THAT THE TROCAR BROKE WHEN INSERTING INSTRUMENT. THE CHANDELIER WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11529681 ↗
• MalfunctionMar 18, 2021Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED THAT WHEN THE TROCAR AND THE CHANDELIER GOT SEPARATE, THE METAL CYLINDER PART CAME OFF OF THE BLUE PLASTIC PART IN THE TROCAR DURING SURGERY. IT WAS NOT A PROBLEM SINCE THE PART CAME OFF WITH THE CHANDELIER. THE PRODUCT WAS REPLACED AND PROCEDURE COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11520706 ↗