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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. INTUITIVE FENESTRATED BIPOLAR FORCEPS 8MM SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. INTUITIVE FENESTRATED BIPOLAR FORCEPS 8MM SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 471205-17
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 12/06/2021
Event Type  malfunction  
Event Description
Cable on the tip broken when in the patient. Surgeon was just grasping tissue. Fda safety report id# (b)(4).
 
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Brand NameINTUITIVE FENESTRATED BIPOLAR FORCEPS 8MM
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
sunnyvale CA
MDR Report Key13334106
MDR Text Key284621576
Report NumberMW5106895
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 01/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471205-17
Device Lot NumberN102105310
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2022
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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