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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI XI TIP-UP FENESTRATED GRASPER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. DA VINCI XI TIP-UP FENESTRATED GRASPER SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 470347
Device Problem Component Missing (2306)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/31/2022
Event Description
Robot tip-up working end missing. Notice after instrument was place into patient. X-ray was performed after case to ensure it was not left in the patient. Fda safety report id# (b)(4).
 
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Brand NameDA VINCI XI TIP-UP FENESTRATED GRASPER
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
MDR Report Key13455121
MDR Text Key285224901
Report NumberMW5107211
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 02/02/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Model Number470347
Device Lot NumberK132112213 0183
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes

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