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

Model Number 471205-17

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 11/09/2021

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted low anterior resection surgical procedure, the customer found a broken conductor wire on the fenestrated bipolar forceps instrument.The customer replaced the fenestrated bipolar forceps instrument with a back-up instrument of the same kind and completed the procedure with no reported injury.Intuitive surgical, inc.(isi) has attempted to obtain additional information related to the event.However, as of the date of this report, no further details have been received.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has requested the fenestrated bipolar forceps instrument for evaluation, but the instrument has not yet been received as of the date of this report.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned for analysis and/or if additional information is received.A review of the logs showed the fenestrated bipolar forceps instrument (part# 471205-17 / lot# n10210329-0295) was last used on (b)(6) 2021 during this reported procedure with system (b)(4).The fenestrated bipolar forceps instrument has 14 allotted uses and had 3 uses remaining.In addition, a review of the site's complaint history identified no other complaints related to the fenestrated bipolar forceps instrument.No image or video clip for the reported event was submitted to isi for review.This complaint is being reported due to the following conclusion: a bipolar instrument with damaged conductor wire insulation could lead to inadvertent transmission to tissue other than intended via the exposed conductor wire.Although there was no patient injury reported, the failure mode could likely cause or contribute to an adverse event if it were to recur.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated/confirmed the customer reported complaint.Failure analysis found the primary failure of the broken conductor wire to be related to the customer reported complaint.The instrument was found to have a broken conductor wire at the yaw pulley.The conductor wire was broken at the grip-crimp location.The instrument failed the electrical continuity test.No signs of thermal damage or damage to the conductor wire insulation were observed.The root cause of this failure is attributed to a component failure.

• 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: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 13050692
• MDR Text Key: 288495697
• Report Number: 2955842-2021-11785
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)N10210329
• 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: Other,Foreign,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471205-17
• Device Catalogue Number: 471205
• Device Lot Number: N10210329 0295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2021
• 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