Single-SiteRecalls & reported problems across all models
Intuitive Surgical, Inc. · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Single-Site model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 292
- Deaths reported
- 0
- Injuries reported
- 64
- Recalls
- 1
We found 12 models of Single-Site by Intuitive Surgical, Inc. in the FDA's device registry (GUDID). Together they are named in 292 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2017 and Sep 21, 2026 — classified as 64 injuries, 228 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (88 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Single-Site recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 6, 2023Open, Classified
There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
Z-0406-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported Single-Site problems
Device problems
- Detachment of Device or Device Component88
- Difficult to Open or Close53
- Break50
- Unintended System Motion38
- Material Split, Cut or Torn27
- Material Fragmentation21
- Material Integrity Problem7
- Unintended Movement7
Patient problems
- No Clinical Signs, Symptoms or Conditions222
- Insufficient Information43
- Foreign Body In Patient19
- Device Embedded In Tissue or Plaque6
- No Known Impact Or Consequence To Patient5
- Unspecified Tissue Injury2
- Hemorrhage/Blood Loss/Bleeding1
Single-Site models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Single-Site 478115Laparoscope, general & plastic surgery1 recall61 reports
- Single-Site 478090System,surgical,computer controlled instrument72 reports
- Single-Site 478093System,surgical,computer controlled instrument56 reports
- Single-Site 478053System,surgical,computer controlled instrument55 reports
- Single-Site 478055Laparoscope, general & plastic surgery20 reports
- Single-Site 478059Laparoscope, general & plastic surgery14 reports
- Single-Site 478058System,surgical,computer controlled instrument5 reports
- Single-Site 478080System,surgical,computer controlled instrument4 reports
- Single-Site 478071Laparoscope, general & plastic surgery2 reports
- Single-Site 478054Laparoscope, general & plastic surgery1 report
- Single-Site 478057Laparoscope, general & plastic surgery1 report
- Single-Site 428054Laparoscope, general & plastic surgery1 report
Recent Single-Site adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Entrapment of Device
It was reported that during a da Vinci-assisted surgical procedure, the instrument did not move while tissue was trapped. The customer removed the instrument using the Instrument Release Kit (IRK). The procedure was completed with no reported injury.ISI followed up with the initial reporter and obtained the following additional information: The tissue adhered to the instrument was gallbladder tissue inside the jaws. No tissue was removed during the event. There was no bleeding due to this event. The patient did not experience any post operative complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842877 ↗MalfunctionJul 27, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information
MAUDE report 50016102 ↗InjuryMay 14, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE TIP OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT DETACHED; THE SURGERY WAS IMMEDIATELY CONTINUED AFTER REPLACING IT WITH A BACKUP INSTRUMENT. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE; THE DETACHED TIP WAS REMOVED IMMEDIATELY, ALL VISUALLY IDENTIFIABLE FRAGMENTS WERE REMOVED (1 FRAGMENT), AND THE PATIENT SHOWED NO ABNORMALITIES. THE PROCEDURE WAS DELAYED FOR APPROXIMATELY 5 MINUTES FOR INSTRUMENT REPLACEMENT AND FRAGMENT REMOVAL. THERE WAS NO BLEEDING AND NO PATIENT ABNORMALITIES. THE FRAGMENT REMOVAL WAS COMPLETED AND ENCLOSED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT USED DURING THE SURGICAL PROCEDURE WAS INSPECTED BEFORE USE, WITH NO DAMAGE OR ABNORMALITIES OBSERVED AT THAT TIME. DURING THE SURGERY, A DEVICE FRAGMENT UNEXPECTEDLY FELL INSIDE THE PATIENT; HOWEVER, THERE WAS NO EVIDENCE OF INSTRUMENT COLLISION OR ACCESSORY TIP IMPACT THAT COULD HAVE CAUSED THE ISSUE. THE PRECISE SURGICAL TASK ONGOING WHEN THE FRAGMENT FELL, AS WELL AS THE SU
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25172302 ↗MalfunctionApr 18, 2026Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Insufficient Information
MAUDE report 24919907 ↗MalfunctionApr 3, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE TIP AND THE TUBE OF THE SINGLE SITE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT BECAME BENT AND SEPARATED, RENDERING IT UNUSABLE. THERE WERE NO REPORTS OF FRAGMENTS FALLING INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24783612 ↗MalfunctionApr 1, 2026Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Insufficient Information
MAUDE report 24750969 ↗MalfunctionApr 1, 2026Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Insufficient Information
MAUDE report 24750954 ↗MalfunctionApr 1, 2026Break
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK INSTRUMENT COVER WAS PEELING OFF. THE PROCEDURE WAS COMPLETED AS PLANNED. INTUITIVE FOLLOWED UP AND OBTAINED ADDITIONAL INFORMATION. THE PEELED COVERINGS OF THE PERMANENT CAUTERY HOOK WERE NOT EXPOSED. NO ARCING. THERE WERE NO SIGNS OF THERMAL DAMAGE AT SITE OF THE BREAKAGE. THE TIP SEPARATED, MAKING CAUTERY FUNCTION IMPOSSIBLE. THERE WAS NO INJURY. IT WAS REPORTED THAT WHILE THE DEVICE WAS CAUTERIZING THE TISSUE, THERE WERE COATING PEELING. THERE WAS NO SEPARATION, BUT THE TIP APPEARED TO WEAKEN, EXHIBITING A MOVEMENT SIMILAR TO WOBBLING. ULTIMATELY, THE TIP DETACHED WHILE REMOVING THE INSTRUMENT FROM THE 5X250 CANNULA, RENDERING IT UNUSABLE.
Patient problems: Insufficient Information
MAUDE report 24750914 ↗MalfunctionMar 30, 2026Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Insufficient Information
MAUDE report 24722512 ↗MalfunctionMar 25, 2026Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Insufficient Information
MAUDE report 24684274 ↗MalfunctionMar 17, 2026Break
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24622066 ↗MalfunctionMar 11, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24573670 ↗MalfunctionMar 11, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24566046 ↗MalfunctionMar 10, 2026Device Reprocessing Problem
IT WAS REPORTED THAT PRIOR TO START OF DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, AN OIL-LIKE LIQUID HAD LEAKED FROM THE SURFACE OF THE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 24554784 ↗MalfunctionMar 6, 2026Detachment of Device or Device Component
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24539063 ↗
Other Intuitive Surgical, Inc. products
- EndoWrist62 models · 69,753 reports · 48 recalls
- daVinci Xi4 models · 11,477 reports · 3 recalls
- EndoWrist;daVinci Si35 models · 1,683 reports · 8 recalls
- daVinci 53 models · 1,608 reports · 5 recalls
- da Vinci Surgical System9 models · 1,459 reports · 5 recalls
- Ion6 models · 1,367 reports · 3 recalls
- SureForm16 models · 1,190 reports · 3 recalls
- EndoWrist SP20 models · 993 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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