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

Model Number 470205-17

Device Problems Break (1069); Material Separation (1562)

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

Event Date 05/14/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed the reported failure.There was no material missing; however, the conductor wire was exposed.The instrument passed the electrical continuity test.The root cause is attributed to component failure.A review of the complaint history does not show any additional complaints related to the product.There was no indication that there was a recurrence of the issue.No image or video clip for the reported event was available for review.A system log review was performed, but no errors related to this event would exist in the logs.A review of the device logs for the fenestrated bipolar forceps (part# 470205-17 | lot/serial# (b)(4)) associated with this event has been performed.Per this review of the logs, the fenestrated bipolar forceps was last used on (b)(6) 2021 via system serial# (b)(4).There were 2 uses remaining after this last usage.This last usage of the device was before the reported event date, indicating that the device did not pass recognition or the issue was identified before installation on the reported event date.The fenestrated bipolar forceps is a multiple-use electrosurgical endoscopic instrument 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, this complaint is considered a reportable malfunction due to the following conclusion: it was alleged that the instrument had conductor wire damage after a procedure, with no evidence or claim of user mishandling or misuse.A damaged/broken conductor wire has potential for electrical discharge at a location other than intended.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 after a da vinci-assisted pulmonary lobectomy surgical procedure, the fenestrated bipolar forceps instrument had a broken conductor wire at the jaws.There was no intraoperative interference and the instrument functioned as intended.The issue was identified during cleaning and reprocessing.The procedure was reportedly completed with no reported injury.

• Brand Name: ENDOWRIST
• Type of Device: FENESTRATED 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 11988207
• MDR Text Key: 267320897
• Report Number: 2955842-2021-10639
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112359
• UDI-Public: (01)00886874112359(10)N12200317
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470205-17
• Device Catalogue Number: 470205
• Device Lot Number: N12200317 0136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Date Manufacturer Received: 05/17/2021
• 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