Clearify 21-345Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 10884521213562), received between Sep 30, 2016 and Feb 2, 2026 — classified as 4 injuries, 97 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (47 reports).

2 other recalls cover devices cleared under the same FDA submission (K062779); they may or may not involve this specific model.

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 101 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO A LAPAROSCOPIC PROCEDURE, A 5MM LAPAROSCOPE WAS USED AND AFTER THE SCOPE WAS WARMED UP AND REMOVED FROM THE DEVICE, THE PLASTIC COMPONENT THAT CHANGES THE SIZE OF THE SCOPE AT THE OPENING OF THE SYSTEM FELL OFF. THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24233573 ↗
• MalfunctionJan 22, 2026

  DEVICE WOULD NOT TURN ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24150114 ↗
• MalfunctionJul 17, 2025Contamination

  HAIR NOTED ON VISUALIZATION SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 22529804 ↗
• MalfunctionJun 24, 2025Component Missing

  MISSING THE WHITE PAD INSIDE IN THE BOTTOM-ONLY HARD METAL WAS PRESENT, DOES NOT CONTAIN THE PIECE THAT ENABLES THE MAIN FEATURE-TO WHITE BALANCE A SCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318620 ↗
• MalfunctionJun 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE SPONGE-CLEANING COMPONENT OF THE DEVICE BROKE OFF INSIDE THE BLUNT PORT. THE TROCAR CLEANER WAS BEING USED TO CLEAN THE PORT AT THE TIME OF THE ISSUE. NO COMPONENT FELL INTO THE CAVITY OF THE PATIENT. TO RESOLVE THE ISSUE, THE DEVICE AND PORT WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153183 ↗
• MalfunctionApr 30, 2025Contamination; Device Damaged Prior to Use

  THE SYSTEM WAS REMOVED FROM THE BOX AND A BROWN SUBSTANCE WAS NOTICED IN THE PEEL PACK. IT WAS NOT PLACED ON THE STERILE FIELD AND DID NOT CAUSE ANY DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934072 ↗
• MalfunctionApr 18, 2025Break; Overheating of Device; Break; Overheating of Device

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, IT APPEARED THAT THE BATTERY HAD EXPLODED. THE DEVICE WAS TURNED ON PRIOR TO USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864626 ↗
• MalfunctionApr 2, 2025Sparking; Sparking

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, TWO DEVICES SPARKED AND CAUGHT FIRE. IT WAS NOTED THAT ALL DEVICES FROM THE SAME LOT NUMBER HAVE BEEN PULLED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751287 ↗
• MalfunctionApr 2, 2025Sparking; Sparking

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, TWO DEVICES SPARKED AND CAUGHT FIRE. IT WAS NOTED THAT ALL DEVICES FROM THE SAME LOT NUMBER HAVE BEEN PULLED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751201 ↗
• MalfunctionMar 14, 2025Mechanical Problem; Failure to Power Up; Mechanical Problem; Failure to Power Up

  ACCORDING TO THE REPORTER, PRIOR TO USE THE DEVICE DID NOT TURN ON. IT WAS NOTED THAT THE PATIENT HAD AN INFECTION, HENCE. THE PATIENT CANNOT BE TAKEN OUT OF THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 21610426 ↗
• MalfunctionJan 27, 2025

  MISSING WHITE MATERIAL AT THE BASE OF IGLOO, THIS WAS UNGLUED WHEN REMOVED FROM THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21240405 ↗
• MalfunctionJan 6, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLECTOMY, A PIECE OF A COTTON SWAB BROKE FROM THE VISUALIZATION SYSTEM FELL INTO THE PATIENT'S CAVITY AT THE BEGINNING OF THE CASE. THE PIECE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT, AND A NEW SWAB WAS OPENED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080838 ↗
• MalfunctionNov 27, 2024Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHILE PREPARING, THE BOTTOM PART OF THE DEVICE CAME OFF. THE SOLUTION THEN LEAKED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20801484 ↗
• MalfunctionNov 12, 2024

  PRIOR TO PATIENT ENTERING OR (OPERATING ROOM), THE SURGICAL TECH TURNED ON THE CLEARIFY VISUALIZATION SYSTEM. IT BEGAN SMOKING AND WAS HOT TO THE TOUCH. THE DEVICE WAS IMMEDIATELY TURNED OFF AND REMOVED FROM THE OPERATING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662078 ↗
• MalfunctionAug 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY OF A ROBOTIC LAPAROSCOPIC PROCEDURE, THE BOTTOM OF THREE ANTI-FOGGING DEVICES FROM THE SAME LOT NUMBER FELL OFF. THE BATTERIES FELL INTO THE STERILE FIELD. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19946943 ↗
• MalfunctionAug 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY OF A ROBOTIC LAPAROSCOPIC PROCEDURE, THE BOTTOM OF THREE ANTI-FOGGING DEVICES FROM THE SAME LOT NUMBER FELL OFF. THE BATTERIES FELL INTO THE STERILE FIELD. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19940785 ↗
• MalfunctionAug 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY OF A ROBOTIC LAPAROSCOPIC PROCEDURE, THE BOTTOM OF THREE ANTI-FOGGING DEVICES FROM THE SAME LOT NUMBER FELL OFF. THE BATTERIES FELL INTO THE STERILE FIELD. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19940600 ↗
• MalfunctionJul 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOTIC SURGERY, WHEN THE SURGICAL TECH WAS CLEANING THE TROCAR WITH THE SWAB FROM THE DEVICE, THE TIP OF THE SWAB CAME OFF AND FELL INTO PATIENT CAVITY. THE TIP OF THE SWAB WAS REMOVED THROUGH THE TROCAR. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19842180 ↗
• MalfunctionMar 29, 2024Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE DEVICE WAS TAKEN OUT FROM THE BOX, THE APPEARANCE OF THE DEVICE WAS SCRATCHED AND DAMAGE WAS OBSERVED, SO IT WAS NOT USED. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19006492 ↗
• MalfunctionFeb 28, 2024Leak/Splash; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SOLUTION LEAKED AND THERE WAS A HAIR ON IT. THE SURGICAL PROCEDURE WAS EXTENDED 30 MINUTES OR MORE DUE TO THE STAFF BREAKING DOWN THE ROOM AND RESETTING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18797205 ↗
• MalfunctionJan 18, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, THE DEVICE SYSTEM CAME APART WHEN CHANGING POSITION IN THE STERILE FIELD. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18539593 ↗
• MalfunctionJan 11, 2024Failure to Power Up; Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Failure to Power Up; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE DID NOT TURN ON. ADDITIONAL DEVICES WERE OPENED TO FIND MORE CONTAMINATED WITH BROWN CRUSTY RUST INSIDE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY 40 MINUTES DUE TO THE DEVICE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18498447 ↗
• MalfunctionJan 11, 2024Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE DID NOT TURN ON. ADDITIONAL DEVICES WERE OPENED TO FIND MORE CONTAMINATED WITH BROWN CRUSTY RUST INSIDE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY 40 MINUTES DUE TO THE DEVICE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18498324 ↗
• MalfunctionJan 11, 2024Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE DID NOT TURN ON. ADDITIONAL DEVICES WERE OPENED TO FIND MORE CONTAMINATED WITH BROWN CRUSTY RUST INSIDE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY 40 MINUTES DUE TO THE DEVICE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18498118 ↗
• MalfunctionJan 11, 2024Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE DID NOT TURN ON. ADDITIONAL DEVICES WERE OPENED TO FIND MORE CONTAMINATED WITH BROWN CRUSTY RUST INSIDE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY 40 MINUTES DUE TO THE DEVICE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18498024 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062779. One submission often covers many models, so check the product and lot details in each record.

• Z-0890-2017 · Oct 4, 2016 · Terminated
  Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic proce
• Z-0889-2017 · Oct 4, 2016 · Terminated
  Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as