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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC. DA VINCI PROGRASP FORCEP SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number XI
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 12/01/2021
Event Type  malfunction  
Event Description
This xi robotic instrument locked during the case. It failed to allow for manipulation. Cable broke. It will be returned to intuitive for the remaining 3/10 lives. Fda safety report id# (b)(4).
 
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Brand NameDA VINCI PROGRASP FORCEP
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
MDR Report Key13077357
MDR Text Key282816214
Report NumberMW5106253
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 12/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberXI
Device Catalogue Number471093
Device Lot NumberK10210503 0038
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2021
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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