MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MARYLAND BIPOLAR FORCEPS

Model Number 470172-16

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the maryland bipolar forceps instrument involved in this case and failure analysis testing has been performed.Failure analysis was able to replicate and confirm the reported complaint.The bipolar yaw pulley with thermal damage between the grip tips was the primary finding and related to the reported event.The instrument was found to have charring and localized melting at the grip base between the grips.The instrument passed the electrical continuity test.No damage to the conductor wire was observed.The root cause of thermal damage between the grips and at the bipolar yaw pulley is typically attributed to mishandling/misuse, most commonly caused by insulation degradation and carbonized tissue creating a conductive pathway.A secondary finding of bipolar yaw pulley with thermal damage was found, and was determined to be related to the customer's reported complaint.The bipolar yaw pulley exhibited localized melting damage at the base of one of the grip tips.The root cause of this failure is attributed to mishandling/misuse.A review of the procedure log confirmed the surgical procedure was performed on the reported event date matching the documented event details.A review of the instrument logs showed the maryland bipolar forceps instrument (part# 470172-16 / lot# n10210419-0154) was last used on (b)(6) 2022 during a common bile duct exploration procedure with system (b)(4).The maryland bipolar forceps instrument had 2 uses remaining.An image of the maryland bipolar forceps instrument related to this event was received.A review of the submitted image was performed by an intuitive surgical, inc.(isi) failure analysis engineer (fae).The following additional information was provided: this looks like there is thermal damage to the yaw pulley.This complaint is being reported due to the following conclusion: it was alleged that the maryland bipolar forceps instrument "insulating material" was damaged and formed a black ball.In addition, the failure analysis of the instrument revealed thermal damage between the grip tips and also at the bipolar yaw pulley.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.

Event Description

It was reported that during a da vinci-assisted common bile duct exploration surgical procedure, the customer noted that the maryland bipolar forceps instrument was used to coagulate the greater omentum, and the "insulating material" at the head of the instrument was damaged and formed a black ball.The procedure was completed with the same maryland bipolar forceps instrument with no reported injury.On 28-jun-2022, intuitive surgical, inc.(isi) performed follow-up and obtained the following additional information regarding the reported event: the instrument was reportedly inspected prior to use, and no issues were noted.The surgeon was about to grasp tissue at the time of the event.No arcing and instrument collision were observed during the procedure.The conductor wire insulation was not damaged.It was confirmed there was no patient harm, injury or adverse outcome.On 01-jul-2022, isi performed follow-up and obtained the following additional/updated information regarding the reported event: a video recording of the procedure is not available, but an image of the instrument damage was provided.

• Brand Name: ENDOWRIST
• Type of Device: MARYLAND BIPOLAR FORCEPS
• 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 Key: 14973751
• MDR Text Key: 295594745
• Report Number: 2955842-2022-12897
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112281
• UDI-Public: (01)00886874112281(11)210415(10)N10210419
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• 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
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470172-16
• Device Catalogue Number: 470172
• Device Lot Number: N10210419 0154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES