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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. CADIERE FORCEPS SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. CADIERE FORCEPS SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 471049
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2022
Event Type  malfunction  
Event Description
One of the turning knobs where the robot instrument connects to the drape broke off.
 
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Brand NameCADIERE FORCEPS
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key14336454
MDR Text Key291214933
Report Number14336454
Device Sequence Number1
Product Code NAY
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 04/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number471049
Device Catalogue Number471049
Device Lot NumberK10211206 0021
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/18/2022
Event Location Hospital
Date Report to Manufacturer05/09/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/09/2022 Patient Sequence Number: 1
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