None 470035Recalls & reported problems
Intuitive Surgical, Inc. · HANDHELD CAMERA HEAD · Class 2
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00886874115725), received between May 27, 2022 and Apr 1, 2026 — classified as 2 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component4
- Break2
- Crack2
- Material Integrity Problem2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Material Fragmentation1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Insufficient Information6
- Unspecified Tissue Injury1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2026Detachment of Device or Device Component
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Insufficient Information
MAUDE report 24750916 ↗MalfunctionMar 14, 2026Crack
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Insufficient Information
MAUDE report 24600386 ↗MalfunctionMar 5, 2026Break
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Insufficient Information
MAUDE report 24526248 ↗MalfunctionMay 23, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HANDHELD CAMERA HEAD HAD A PLASTIC PIECE BROKE OFF. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE STERILE PROCESSING MANAGER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CLARIFIED THAT THE PIECE WAS BROKEN OFF FROM THE PROXIMAL END OF THE CAMERA THAT DOES NOT ENTER THE PATIENT. THE ISSUE WAS IDENTIFIED PRIOR TO STARTING THE PROCEDURE PRE-ANESTHESIA. THE CUSTOMER CONFIRMED THAT THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS A PIECE OF PLASTIC BROKEN OFF THE DISTAL END OF THE CAMERA. NO IMAGES OR PATIENT DEMOGRAPHICS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22081380 ↗MalfunctionOct 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Insufficient Information
MAUDE report 20425175 ↗MalfunctionOct 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING CENTRAL PROCESSING THE HANDHELD CAMERA HEAD THERE HAD A PLASTIC PIECE THAT BROKE OFF THE ENDOSCOPE. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. ON 9/23/2024, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND GATHERED THE FOLLOWING INFORMATION: THE ISSUE WAS IDENTIFIED WHEN THE CAMERA WAS OPENED ON A STERILE FIELD. TECH NOTICED A PART OF THE PLASTIC ON CAMERA WAS MISSING. FRAGMENT DID NOT FALL INTO THE PATIENT. THE BROKEN PART WAS NOT RETURNED FROM CENTRAL PROCESSING. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20381511 ↗MalfunctionOct 4, 2024No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE HANDHELD CAMERA HEAD WAS BROKEN. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 20365521 ↗InjuryOct 1, 2024Break; Break
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Unspecified Tissue Injury
MAUDE report 20348926 ↗MalfunctionAug 31, 2024Material Fragmentation; Material Fragmentation
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20113845 ↗MalfunctionAug 23, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Insufficient Information
MAUDE report 20048221 ↗MalfunctionAug 15, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, A BROKEN PIECE FELL OFF THE HANDHELD CAMERA HEAD. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19988911 ↗MalfunctionMar 14, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HANDHELD CAMERA HEAD WAS SMOKING. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18909513 ↗InjuryAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17638037 ↗MalfunctionMay 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING CENTRAL PROCESSING, BROKEN LENS WERE NOTED ON THE ENDOSCOPE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16971303 ↗MalfunctionMay 21, 2023Crack; Crack
IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HANDHELD CAMERA HEAD WAS FOUND TO HAVE A CRACK IN THE LENS. THE DEVICE WAS NOT USED ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16971261 ↗MalfunctionMar 30, 2023No Display/Image; No Display/Image
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16641357 ↗MalfunctionMay 27, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA REPAIR SURGICAL PROCEDURE, THE HANDHELD CAMERA LIGHT CORD TUBE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER REPORTED THAT THE PROCEDURE PERFORMED WAS AN INGUINAL HERNIA REPAIR ON (B)(6) 2022. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WERE NO ISSUES NOTED. NO IMAGE OR PROCEDURE VIDEO WAS AVAILABLE FOR REVIEW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14520318 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.