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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 09/29/2017
Event Type  Injury  
Manufacturer Narrative
The fenestrated bipolar forceps instrument involved with this event has been returned and evaluated. During failure analysis, the instrument was found to have a severely bent grip, causing side to side misalignment of the grips. There was a 0. 055" offset at the tips. Grip performance and energy activation performance was reduced since the distal tips no longer meet. The known common cause of this failure is mishandling/misuse. No signs of charring or black marks were observed at the grip assembly. The instrument passed the electrical continuity test. 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 instrument caused "trauma" to the patient's tissue. On (b)(4) 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 Key7362625
MDR Text Key103204641
Report Number2955842-2018-10090
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
Device Operator
Device Model Number420205-13
Device Lot NumberN10170113 181
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 Manufactured01/12/2017
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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