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

Model Number 420205-16

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  

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.An image of the fenestrated bipolar forceps instrument related to this event was received.A review of the submitted image was performed by an isi failure analysis engineer.The following additional information was provided: it is hard to tell from the image, but it looks like the conductor wire insulation is damaged.A review of the logs showed the fenestrated bipolar forceps instrument (part# 420205-16 / lot# n10201130-868) was last used on (b)(6) 2021 during a procedure with system (b)(4).The fenestrated bipolar forceps instrument has 10 allotted uses and had 6 uses remaining.In addition, a review of the site's complaint history does not show any additional complaints related to this product and/or this event.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.

Event Description

It was reported that prior to the start of a da vinci-assisted nephrectomy surgical procedure, the customer discovered the front wire of the fenestrated bipolar forceps instrument was broken.There was no report of any fragments falling inside the patient.The procedure was completed with no reported injury.On 29-nov-2021, intuitive surgical, inc.(isi) performed follow-up with the customer and obtained additional information regarding the reported event.The instrument was reportedly inspected prior to use, and no issues were noted.The instrument did not collide with any other instrument or tool during the procedure.The customer reported that the conductor wire insulation was not damaged.It was confirmed that no fragments fell inside the patient during the procedure.There is no video recording of the procedure, but an image of the instrument damage was provided.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Additional information can be found in the following fields: d9, g3, g6, h2, h3, h6, and h10.D02 - 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 finding of the damaged conductor wire insulation to be related to the customer reported complaint.The instrument was found to have insulation damage on the conductor wire.The conductor wire insulation had a slash, exposing the electrical wires.There was no material missing.The electrical continuity test was performed and passed.The root cause of this failure is attributed to a component failure.

• Brand Name: ENDOWRIST; DAVINCI SI
• 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: 12960156
• MDR Text Key: 286445001
• Report Number: 2955842-2021-11692
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111642
• UDI-Public: (01)00886874111642(10)N10201130
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420205-16
• Device Catalogue Number: 420205
• Device Lot Number: N10201130 868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 01/13/2022
• Supplement Dates FDA Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2020
• 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
• Patient Race: Asian