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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DAVINCI SEAL CAP FOR 8MM PORT; LAPAROSCOPE, GENERAL PLASTIC SURGERY
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INTUITIVE SURGICAL, INC. DAVINCI SEAL CAP FOR 8MM PORT; LAPAROSCOPE, GENERAL PLASTIC SURGERY Back to Search Results
Model Number 470361
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/07/2022
Event Type  malfunction  
Event Description
8mm cannula seal on three davinci robotic procedures had defective seals.Lot# l10220717.Remaining seals (3) from this lot were pulled from inventory.Davinci rep [redacted name], materials, [redacted name], apsm [redacted name], psm all notified.No harm to patient new cannula for fore-mentioned cases was obtained.Manufacturer response for seal cap, davinci seal cap for 8mm port (per site reporter) [redacted date] [redacted name], reached out to site for product information.[redacted name] reached out to site and cc'd [redacted name], to confirm if the manufacturer acknowledged a widespread defect with this lot which would require broader messaging on our side.[redacted date] [redacted name] has notified the manufacturer and is sending it back on [redacted date].[redacted date] [redacted name] asked [redacted name] for the item number for fda reporting.
 
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Brand Name
DAVINCI SEAL CAP FOR 8MM PORT
Type of Device
LAPAROSCOPE, GENERAL PLASTIC SURGERY
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key16101872
MDR Text Key306707214
Report Number16101872
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number470361
Device Catalogue Number470361
Device Lot NumberL10220717
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/19/2022
Event Location Hospital
Date Report to Manufacturer01/05/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/05/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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