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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI MONOPOLAR CURVED SCISSORS

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INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI MONOPOLAR CURVED SCISSORS Back to Search Results
Model Number 420179-23
Device Problems Thermal Decomposition of Device (1071); Arcing (2583); Defective Device (2588)
Patient Problems Bowel Burn (1756); Burn(s) (1757)
Event Date 06/13/2022
Event Type  Injury  
Event Description
It was reported that during a da vinci-assisted prostatectomy procedure, a burning accident occurred while the surgeon was using a monopolar curved scissors (mcs) instrument at the beginning of the procedure. The tip of the mcs instrument heated up and burst into flames when the surgeon activated the mcs instrument for the first time. The mcs instrument was on its third usage. There was injury to the patient's small intestine and abdominal wall near the trocar as a result. A backup mcs instrument with tip cover was used. The fragments that fell in the patient from the burnt tip cover were retrieved during the same procedure. Intuitive surgical, inc. (isi) followed up with the operating room nurse and obtained the following information: there was no error generated by the system after installing the instrument. The flame was seen arising from the tip of the mcs. When the instrument was removed from the cannula, the mcs instrument was still flaming. The surgeon sutured the hole in the intestine and cleaned up the residue. The surgeon used a backup force triad generator, new cautery cable, mcs instrument and tip cover to complete the procedure. The patient did not have any implants. No further details of the patient could be provided from the site. The gas used for insufflation was co2, which comes from lines on the wall. The insufflator brand used for the procedure was storz. There was no possibility of oxygen being insufflated into the patient. The last time the gas source was checked was on the morning of the incident. The engineer reportedly checks the gas system twice/day. The neutral pad was placed at the lateral thigh. The facility does not use multiple pads on the patient. The cannulas used were da vinci 8 mm cannulas and a medtronic cannula for the endoscope. The settings for the generator were: cut 60 pure, coag 60 fulg. The surgeon was aware of the energy settings used.
 
Manufacturer Narrative
Based on the current information provided, the cause of the intra-operative complication is unknown. Although thermal damage of the tube extension is typically attributed to mishandling/misuse, there is no information available from follow-up that attributes the root cause of the arcing to a use issue. Failure analysis (fa) of the mcs instrument showed that the conductor wire damage is due to a component failure. A follow-up mdr will be submitted if additional information is received. Isi has received the mcs instrument associated with this complaint and completed investigations. Fa investigations replicated/confirmed the customer reported complaint. The instrument was found to have a melted and charred tube clevis. The proximal clevis was not physically damaged. Based on the customer report, there was a mcs tip cover accessory installed on the instrument at the time of the failure. The mcs tip cover accessory was not returned with the instrument, however, there are traces of a melted, shiny silicone resembling substance on the distal tip of the instrument that was present all the way down the tube extension (to the extent of the thermal damage). The proximal clevis was bent in order to observe the internal area of the tube extension. Visual inspection within the tube extension found charring and extensive signs of thermal damage. The root cause of thermal damage to the tube extension is typically attributed to mishandling/misuse, likely caused by improper usage of energy output. When the proximal clevis was bent to inspect the inside of the tube extension, the conductor wire was found to be broken at the distal end, with signs of charring and localized melting, which is indicative of arcing. The housing was removed from the back end, no signs of damage was observed. The broken conductor wire is related to the cause of the tube extension thermal damage; however, the root cause is attributed to a component failure. Additional observation(s) not reported by site: the instrument was found to have a broken grip cable at the proximal clevis. There was no thermal obvious thermal damage to the cable found at the point of breakage. The root cause of broken distal grip cables is attributed to a component failure. The instrument was also evaluated by isi engineering and the following findings were obtained: the initial findings were confirmed. The instrument was found to have thermal damage to the tube extension and the proximal clevis. It was additionally observed that on the tube extension and distal clevis there were melted tip cover remains. Electrical continuity was tested and failed indicating a broken conductor wire. The instrument was disassembled, and it was observed that they hypotubes on the distal end exhibited thermal damage. It was further seen that the conductor wire insulation had melted leading up to the conductor wire break. The silicone seal in the proximal clevis was also checked and was found to be intact. The root cause of these failures is not determinable due to the severe damage present on the instrument. An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint. The reported complaint was not reproduced during field evaluation. The mcs instrument (lot #n11210816511, part #420179-23) was seen on site with the protective sheath melting and the tip black. The fse checked the connection between the system and the power platform and there was nothing abnormal seen. The entire system was tested on site and no problems were found. The system logs were reviewed but there was no fault reported. The fse tested the system with the hospital engineer's instrument and the system worked fine. The system was tested and verified as ready for use. The system logs were reviewed by the fse and there were no relevant errors found. Images provided by customer of the reported event were reviewed by an isi clinical development engineer (cde) and the following information was received: the pictures show that the mcs tip cover accessory melted and left residue inside the patient, on the distal tip of the cannula, and on the patient side manipulator (psm) drape. The residue on the cannula and drape were likely left behind when the instrument was removed from the patient. Tissue damage was not observed in the pictures sent. The case was also reviewed by a cde and the following was noted: the energy settings do seem higher than typically seen, which may have contributed to combustion of any potential oxygen within the patient. This complaint is being reported due to the following conclusion: during a da vinci-assisted prostatectomy procedure, a burning accident occurred while the surgeon was using a mcs instrument at the beginning of the procedure. The tip of the mcs instrument heated up and burst into flames when the surgeon activated the mcs instrument for the first time. There was an injury to the patient's small intestine and abdominal wall near the trocar as a result. A backup mcs instrument with tip cover was used to complete the procedure. The fragments that fell in the patient from the burnt tip cover were retrieved during the same procedure.
 
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Brand NameENDOWRIST;DAVINCI SI
Type of DeviceMONOPOLAR CURVED SCISSORS
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer Contact
izabel nielson
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key15009035
MDR Text Key295853324
Report Number2955842-2022-12941
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874111505
UDI-Public(01)00886874111505(10)N11210816
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K180033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420179-23
Device Catalogue Number420179
Device Lot NumberN11210816 511
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2022
Date Manufacturer Received07/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/12/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 07/13/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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