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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC. FENESTRATED BIPOLAR FORCEPS SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Lot Number N10170925-
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/30/2017
Event Type  malfunction  
Event Description
During robot assisted laparoscopic inguinal hernia (lih) repair-surgeon was using fenestrated bipolar grasper to pull suture through tissue and one of two "arms" on grasper broke off inside patient. Piece was able to be retrieved.
 
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Brand NameFENESTRATED BIPOLAR FORCEPS
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
710 venture dr, suite 300
desoto trade center building 1
southaven MS 38672
MDR Report Key7178773
MDR Text Key96874758
Report Number7178773
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberN10170925-
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/05/2017
Event Location Hospital
Date Report to Manufacturer12/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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