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

Model Number 470172-16

Device Problems Melted (1385); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

Isi has not received the product involved with this complaint.If the product is received or if additional information is obtained, a follow-up mdr will be submitted.A review of the instrument log for the maryland bipolar forceps instrument associated with this event confirmed that the instrument was last used on (b)(6) 2020 on system (b)(4).Per logs, the instrument has 1 use remaining.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or video clip for the reported event was submitted for review.The maryland bipolar forceps instruments are multiple-use electrosurgical endoscopic instruments with a grasping tip to be used in conjunction with the da vinci system and an external electrosurgical unit (esu).The instrument is designed to provide energy from the designated location on the instrument (the tip) to the planned anatomical location when used as intended.The energy is activated by pressing the designated pedal on the surgeon side console (ssc).Based on the information provided at this time, this complaint is being reported because: it was alleged that sparks were observed during the procedure and the bipolar instrument in use at the time exhibited signs indicative of thermal damage with no evidence or claim of user mishandling or misuse.At this time, it is unknown what caused the sparks and the thermal damage to occur.While there was no report of 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 gastrectomy surgical procedure, "sparks were scattered." it was reported that upon checking the maryland bipolar forceps instrument which was in use at the time of the issue, the customer noted thermal damage to the insulated part of the instrument.The customer confirmed that the instrument was connected to a force triad generator at the time of the issue.The procedure was completed as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument and cannula were inspected prior to use.The customer could not confirm whether a pin gauge was used to inspect the cannula but did confirm that checks using gauge pins are performed on a daily basis.It is unknown what surgical task was being performed when sparks were observed and how long the instrument was in use prior to the sparks being observed.Normally, a force triad generator coag setting of 70 is selected but the exact setting which was selected when the issue occurred could not be confirmed.A long bipolar grasper instrument was also in use when the sparking event occurred and the customer confirmed that a monopolar cord was not connected to a bipolar instrument.It is unknown whether there was any instrument collision during the procedure and whether the jaws were immersed in liquid or contaminated by carbonized tissue (bio debris) prior to activating the instrument.The instrument tip(s) did not touch any staples, clips, or sutures while energized and it is highly possible that the instrument tip(s) were in contact with tissue when the sparking event occurred.The instrument was removed after the arcing event was observed to be checked for damage and damage was confirmed upon inspection.The customer confirmed that the instrument wrist was straightened upon removal and also confirmed that there was no report of patient injury.According to the customer, it is unknown whether photographic images of the device are available for isi review.

Manufacturer Narrative

61 - intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the customer reported complaint.The instrument was found to have charring and localized melting at the grip base between the grips.This failure is most commonly caused by insulation degradation and carbonized tissue creating a conductive path.The instrument passed the electrical continuity test.The root cause of this failure is attributed to mishandling/misuse.

• Brand Name: ENDOWRIST
• Type of Device: MARYLAND BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10830175
• MDR Text Key: 240055393
• Report Number: 2955842-2020-11190
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112281
• UDI-Public: (01)00886874112281(10)N10191119
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• 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: N10191119 0024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Date Manufacturer Received: 11/30/2020
• 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