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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI FENESTRATED BIPOLAR FORCEPS

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INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI FENESTRATED BIPOLAR FORCEPS Back to Search Results
Model Number 420205-13
Device Problem Use of Device Problem (1670)
Patient Problem Burn, Thermal (2530)
Event Date 02/12/2018
Event Type  Injury  
Manufacturer Narrative
The fenestrated bipolar forceps instrument involved with this event has been returned and evaluated. Failure analysis did not confirm the customer reported complaint. Upon visual and microscopic inspection, no physical damage was found to the grip assembly. Grip tips fully met with no signs of misalignment. No broken or damaged cable was observed. Manual input of the disk knob exhibited intuitive motion. The instrument was placed and driven on an in-house system. The instrument passed the recognition and engagement tests. The instrument moved intuitively with full range of motion in all directions. The grips opened and closed properly and performed grip functions successfully. Housing was removed and found no damage that would cause motion issues at the wrist. The fenestrated bipolar instrument passed the electrical continuity test. Bipolar energy cord was successfully connected to generator and instrument. Energy activation test was then conducted on system with no issues after pressing the pedal on the surgeon console. No faults or error messages appeared during in-house testing. Wet paper towel was held between grips and began to smoke when seal pedal was pressed. Steam generation from the towel indicated active power and a complete circuit. No loss of power and no intermittent energy was observed. Device history record (dhr) review for the device involved with this complaint has been completed. No non-conformances were identified to be related to this complaint. This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, the patient experienced "tissue damage. " as a result, the surgeon placed "surgical" material to repair the tissue. However, at this time, the root cause of the customer reported event is unknown. Based on an evaluation of the fenestrated bipolar forceps instrument, there is no indication that a malfunction of the instrument occurred.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, the tip of the fenestrated bipolar forceps instrument caused "trauma" to the patient's internal tissue. On 01-mar-2018, intuitive surgical, inc. (isi) obtained the following additional information from an or nurse who was informed of the reported event: during the da vinci-assisted surgical procedure, when the fenestrated bipolar forceps instrument was used, the patient allegedly experienced ¿ internal tissue damage. ¿ at that time, the surgeon decided to place ¿surgical material¿ on the burnt tissue. The nurse confirmed there was no arcing observed and there was no change to the setting of the electrosurgical unit. There is no video recording of the procedure. The or nurse could not provide any additional details.
 
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Brand NameENDOWRIST;DAVINCI SI
Type of DeviceFENESTRATED BIPOLAR FORCEPS
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer Contact
tabitha reed
950 kifer rd.
sunnyvale 
4085232100
MDR Report Key7362626
MDR Text Key103205633
Report Number2955842-2018-10091
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 02/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number420205-13
Device Lot NumberN10170913 772
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/11/2017
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: 03/22/2018 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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