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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. XI ROBOTIC SYNCHROSEAL INSTRUMENT SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. XI ROBOTIC SYNCHROSEAL INSTRUMENT SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Catalog Number 480440
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/02/2022
Event Type  Injury  
Event Description
During use of the xi robotic synchroseal instrument, the plastic sheath covering tip of instrument tore off shaft of instrument and was found inside patient. Surgeon and staff members noticed piece of instrument inside patient. The instrument was removed from surgical use and dislodged piece was removed from inside patient. Both instrument and piece were saved and placed in dirty utility room to sent back to company for inspection. Fda safety report id# (b)(4).
 
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Brand NameXI ROBOTIC SYNCHROSEAL INSTRUMENT
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
sunnyvale CA 94086
MDR Report Key14288423
MDR Text Key290947672
Report NumberMW5109522
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 Risk Manager
Type of Report Initial
Report Date 05/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number480440
Device Lot NumberL90210802
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2022
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/04/2022 Patient Sequence Number: 1
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