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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. FENESTRATED BIPOLAR FORCEPS INRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

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INTUITIVE SURGICAL,INC. FENESTRATED BIPOLAR FORCEPS INRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT Back to Search Results
Model Number 420205
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Injury (2348)
Event Date 02/20/2013
Event Type  Injury  
Manufacturer Narrative
On (b)(4) 2013, isi contacted the clinical sales representative (csr) who was present during the surgical procedure. The csr indicated that the surgeon was using a permanent cautery spatula instrument and a fenestrated bipolar forceps instrument to take down the patient's bladder when damage to the patient's bladder occurred; however, it is unknown which instrument caused the damage to the patient's bladder. The csr indicated that there was no malfunction of the site's da vinci si surgical system, instruments or accessories that caused or contributed to the injury sustained by the patient. The csr indicated that the patient had a challenging anatomy and due to the thickness of the patient's bladder, the surgeon experienced some difficulty delineating the patient's bladder planes, causing the surgeon to inadvertently puncture the patient's bladder. The csr indicated that the surgeon repaired the patient's bladder using the da vinci si surgical system and the affected area was repaired with sutures. The csr indicated that the planned surgical was completed and the surgeon has not reported that the patient suffered any post-surgical complications as a result of the reported event. Based on the information provided, it was determined that the da vinci surgical system, instruments and/or accessories likely did not malfunction in a way that caused or contributed to the patient's injury, but, rather due to the patient's challenging anatomy, which caused the surgeon to inadvertently puncture the patient's bladder. Medwatch report 2955842-2013-00961 has been submitted for the permanent cautery spatula instrument that was also being used when the reported event occurred. This report does not admit that the report or information submitted under this report constitutes an admission that the device, intuitive surgical or intuitive surgical employees, caused or contributed to the reportable event.
 
Event Description
It was reported that during a da vinci si hysterectomy procedure, while performing dissection to take down the patient's bladder, the surgeon punctured the patient's bladder. It was reported that the patient had an anatomical issue related to a redundant bladder.
 
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Brand NameFENESTRATED BIPOLAR FORCEPS INRUMENT
Type of DeviceENDOSCOPIC ELECTROSURGICAL INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL,INC.
sunnyvale CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC.
1266 kifer rd, bldg 101
sunnyvale CA 9408 6
Manufacturer Contact
tabitha reed
1266 kifer rd, bldg 101
sunnyvale, CA 94086
MDR Report Key3018441
MDR Text Key10678844
Report Number2955842-2013-00960
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
PMA/PMN Number
K050369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/20/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number420205
Device Lot NumberM10121220 607
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Hospital
Date Manufacturer Received02/20/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/22/2013 Patient Sequence Number: 1
Treatment
DA VINCI SI SYSTEM, INSTRUMENTS, ACCESSORIES & ES
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