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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI CADIERE FORCEP SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. DA VINCI CADIERE FORCEP SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number XI
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
This xi robotic cadiere forcep has a broken cable. Most likely it was noticed during its time in sterile processing as no paperwork was filed in the operating room suite. I will return this instrument to intuitive for reimbursement of remaining lives. Fda safety report id# (b)(4).
 
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Brand NameDA VINCI CADIERE FORCEP
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
sunnyvale 94086
MDR Report Key13118734
MDR Text Key283139580
Report NumberMW5106386
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
Type of Report Initial
Report Date 12/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberXI
Device Catalogue Number471049
Device Lot NumberN10210104 0079
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2021
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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