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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. FENESTRATED BIPOLAR FORCEPS ROBOTIC INSTRUMENT SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. FENESTRATED BIPOLAR FORCEPS ROBOTIC INSTRUMENT SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 471205
Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/28/2022
Event Type  malfunction  
Event Description
Attempted to remove the fenestrated bipolar forceps robotic instrument (ref# 471205) and it would not detach from the patient as it should normally do so. The grasper was not touching any patient tissue at the time it was stuck. No patient harm. Fda safety report id# (b)(4).
 
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Brand NameFENESTRATED BIPOLAR FORCEPS ROBOTIC INSTRUMENT
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
MDR Report Key13691969
MDR Text Key286891607
Report NumberMW5107924
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Service Personnel
Type of Report Initial
Report Date 03/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471205
Device Lot NumberK12210913
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2022
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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