MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; PERMANENT CAUTERY SPATULA

Model Number 470184-13

Device Problem Smoking (1585)

Patient Problem Burn, Thermal (2530)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive has received the pcs instrument associated with this complaint and completed investigations.Failure analysis investigations did not replicate nor confirm the customer reported complaint.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 instrument passed an electrical continuity and energy delivery test with no issues.One of the clevis ears was removed to inspect the conductor cap and conductor wire.Neither the conductor cap nor the conductor wire exhibited any signs of damage.It was noted that the instrument was returned with an excessive amount of bio debris on the yaw pulley as well as the spatula.Site history: as of 14-sept-2020, a review of the site's complaint history does not show any additional complaints related to this product.Log review: a system log review was conducted, which resulted in the following findings: the system logs confirmed the permanent cautery spatula (pcs) instrument part# 470184-13, lot# n11200330-0115 was used on (b)(6) 2020 with system sk2567.It was noted the instrument was used for 0:50:34 minutes and then replaced with pcs part# 470184-13, lot# n11200330-0132.The pcs instrument part# 470184-13, lot# n11200330-0115 had 6 lives remaining.The site did not provide an image or video clip for the reported event for review.Based on the information provided at this time, this complaint is being reported due to the following conclusion: it was reported that during a da vinci-assisted total hysterectomy malignant surgical procedure, the permanent cautery spatula (pcs) was burning and smoking surrounding the tissue on the metal part right above the tip.The procedure was completed with no reported patient injury.While there was report of mild burn on the surrounding tissue, it was confirmed that there was no medical intervention required, and the surgeon had confirmed there was no patient harm.Although failure analysis could not reproduce the reported symptom, and it was confirmed there was no harm or injury to the patient, the reported hazard could likely cause or contribute to an adverse event if it were to recur.Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Implant date is not applicable because the product is not implantable.Initial reporter is blank because it is unknown if the initial reporter submitted a report to the fda.

Event Description

It was reported that during a da vinci-assisted total malignant hysterectomy surgical procedure, the customer noted the permanent cautery spatula (pcs) was burning and smoking surrounding the tissue on the metal part right above the tip.The surgeon stopped use and switched out the pcs instrument for another one to continue.It was noted the surgeon was cutting the right uterine artery when he was using the instrument.The procedure was completed with no reported injury.On 21-aug-2020, and 14-sep-2020, intuitive surgical, inc.(isi) followed up with the robotics coordinator and obtained the following additional information: the patient was a female.The robotics coordinator reported that the permanent cautery spatula (pcs) instrument was inspected prior to use and nothing out of the ordinary was observed.There was no arcing observed, and at the time of the reported issue, the customer was cauterizing using monopolar energy.An erbe generator was used and the cut and coagulation settings were both at 4.Prior to the burning and smoking issue, the robotics coordinator reported that the pcs instrument was in use for 1.5 hours and was never removed during that time.No instrument tip collision was observed during the use of the pcs instrument.When the burning/smoking occurred, the instrument tip was in contact with tissue.It was noted that the grounding pad was placed properly on the patient.The robotics coordinator was informed of the mild burn noted on the surrounding tissue.The burn marks did not show any signs of color change or charring.The robotics coordinator confirmed that there was no excision of burned tissue, and no medical intervention was required.The robotics coordinator also reported that the surgeon had stated "there was no harm to the patient, the instrument smoked, and it was immediately removed." when the pcs instrument was removed, the wrist was straightened and it was replaced with another instrument.The robotics coordinator stated that the patient had not returned to the hospital due to experiencing any post-surgical complications as a result of the smoking/burning.It was noted that the surgeon was unsure what caused the reported issue.The procedure was completed robotically with no patient injury or harm.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Additional information can be found in the following sections: section a, g3, g4, g7, h2, h3, h6, and h10.Corrected information can be found in d10.On 16-sept-2020, the following additional information was obtained: on 16-sept-2020, intuitive surgical, inc.(isi) received user facility report 0300650000-2020-8014 stating: "during surgery, spatula noted to be burning end smoking surrounding tissue on the metal part right above the tip.The burning and smoking were occurring in an area of the instrument that should not be heating up or burning.Surgeon stopped right away and switched the spatula out.At the time this was noticed, the surgeon had already been using the instrument for 1.5 hours.The patient had multiple adhesions in her abdomen pelvis.The patient was not harmed.The instrument had 6/10 lives left on it.(it was it¿s 4th use).The erbe generator was set at blend, cut 4, bipolar 4, and coagulation 4.What was the original intended procedure? robotic hysterectomy with bilat salpingectomy." the following additional patient-related information was also provided: the patient was a 45 year old african american female, weighing 75 kgs.

• Brand Name: ENDOWRIST
• Type of Device: PERMANENT CAUTERY SPATULA
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10533415
• MDR Text Key: 206916067
• Report Number: 2955842-2020-10905
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112328
• UDI-Public: (01)00886874112328(10)N11200330
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470184-13
• Device Catalogue Number: 470184
• Device Lot Number: N11200330 0115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.; DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Age: 45 YR
• Patient Weight: 75