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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. SUREFORM 60 SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. SUREFORM 60 SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 48/0460
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Insufficient Information (4580)
Event Date 03/24/2022
Event Type  malfunction  
Event Description
A 60 robotic stapler fired successfully 4 times then 60 robotic stapler error intra-operatively stating: "not initializing - reinsert stapler". Reinserted multiple times after cleaning stapler. Attempted with different colored staple loads (white/blue) readjusted arm drape, then replaced drape. Continued error message. Fda safety report id# (b)(4).
 
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Brand NameSUREFORM 60
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
MDR Report Key13938318
MDR Text Key288182835
Report NumberMW5108560
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 03/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number48/0460
Device Lot NumberT90220111
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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