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

Model Number 470172-16

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the maryland bipolar forceps instrument involved with this complaint.And completed the device evaluation.Visual inspection identified damaged conductor wire insulation near the yaw pulley exit, exposing the bare wire.A material of the conductor wire insulation measuring approximately 0.05¿ x 0.04¿ was missing on the area of the damage.No thermal damage identified.The known common cause of this failure is attributed to instrument mishandling, and misuse.The instrument was subjected to electrical continuity and passed testing.Site history review: a review of the site's complaint history does not show any additional complaints related to this product and/or this event.No procedure video, or image was submitted to isi for review; no additional technical analysis was conducted.System log investigation: a review of the instrument log for the maryland bipolar forceps instrument lot# n12200330 / sequence 0017 associated with this event has been performed.Per logs, the instrument was last used for a procedure on (b)(6) 2020 using system sk1542.Instrument has 8 remaining usable lives with no subsequent use recorded.Based on the information provided at this time, this complaint is being classified as a reportable malfunction event due to the following conclusion: 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).It was reported that prior to starting central processing, the customer conducted an inspection, and found that the insulation of the conductor wire of the maryland bipolar forceps instrument was frayed.No patient involvement was reported.The outer layer of the conductor wire is the insulation, therefore if the customer alleged a frayed conductor wire, and the insulation was likely compromised.There was no issue related to unintended energy discharge or arcing on the last recorded instrument usage ((b)(6) 2020 using system sk1542).Evaluation by failure analysis confirmed a damaged conductor wire insulation with a passed electrical continuity.The known common cause of this failure is attributed to instrument mishandling and misuse.The customer reported complaint does not itself constitute an mdr reportable event, however, this complaint is being reported because damage to the conductor wire within the instrument could lead to unintended electrical discharge at a location other than intended.Although there was no arcing reported, or seen through analysis, and there was no patient injury reported, if this failure were to recur, it could cause, or contribute to an adverse event.This instrument has 10 usages allotted to it, which are tracked by the da vinci surgical system.The instrument has 8 remaining usable lives, therefore, had not expired.The product is not implantable.

Event Description

It was reported that during central processing, the customer identified a frayed conductor wire on the maryland bipolar forceps instrument.There was no report of patient involvement.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information regarding the reported event: the reporter was unable to confirm if an issue related to unintended energy discharge, arcing, or instrument collision had occurred on the last known instrument usage ((b)(6) 2020 using system sk1542).

• Brand Name: ENDOWRIST
• Type of Device: MARYLAND BIPOLAR FORCEPS
• 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: 10738795
• MDR Text Key: 213179862
• Report Number: 2955842-2020-11125
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112281
• UDI-Public: (01)00886874112281(10)N12200330
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• 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: N12200330 0017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Date Manufacturer Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2020
• 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