MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; BIPOLAR GRASPER, LONG

Model Number 470400-10

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Burn, Thermal (2530); No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed that the long bipolar grasper instrument had damaged insulation to the conductor wire at the distal idler pulley.Material appeared to be removed, exposing the bare wire.Material appeared to be missing, with the piece being approximately 0.03" x 0.03".The electrical continuity test still passed.No thermal damage was observed at the wrist assembly.The long bipolar grasper 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).A site history review was performed and no related complaints were found to the product.Image/video review: no image or video clip for the reported event was submitted for review.An instrument log review confirmed that the long bipolar grasper instrument (470400-10/n10200317 0006) was last used on (b)(6) 2020 on system (b)(4) and had 3 uses remaining.This complaint is being reported because a bipolar instrument with damaged conductor wire insulation could lead to inadvertent transmission to tissue other than intended via the exposed conductor wire.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.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.Recall is not applicable.

Event Description

It was reported that during central processing the customer found damage to the long bipolar grasper instrument.There was no patient involvement.Intuitive surgical, inc.(isi) followed up with the reporter to attempt to obtain additional information.The da vinci coordinator confirmed that the issue was identified during central processing and that no additional information about the event was available.

• Brand Name: ENDOWRIST
• Type of Device: BIPOLAR GRASPER, LONG
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10591763
• MDR Text Key: 208784479
• Report Number: 2955842-2020-10984
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874113530
• UDI-Public: (01)00886874113530(10)N10200317
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470400-10
• Device Catalogue Number: 470400
• Device Lot Number: N10200317 0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2020
• 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.