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 Insufficient Information (4580)

Event Date 11/24/2021

Event Type  malfunction  

Manufacturer Narrative

An rma has been issued to the customer requesting to have the instrument returned; however, isi has not yet received the fenestrated bipolar forceps for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if additional information is obtained.A review of the device logs for the fenestrated bipolar forceps (part# 471205-17 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)(6).There were 2 uses remaining after this last usage.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No photo or video was provided by the site for review.This complaint is being reported due to the following conclusion: it was alleged that the instrument had conductor wire damage during central processing, with no evidence or claim of user mishandling or misuse.The 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.Blank mdr fields: follow-up was attempted, but the patient information i.E patient race, ethnicity, relevant tests, results, and patient medical history were not provided.The expiration date is not applicable.The product is not implantable.

Event Description

It was reported that during central processing, the black wire of the fenestrated bipolar forceps instrument was torn.The procedure was completed with no reported injury.On (b)(6) 2021, intuitive surgical (is) contacted the site and obtained the following additional information regarding this event: the last procedure in which the instrument was used was completed without any problems.The issue was identified during central processing and no patient injury.Further details were not provided.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

D02- intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed/replicated the customer reported complaint.Fa found the primary failure of 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: 13049934
• MDR Text Key: 290150725
• Report Number: 2955842-2021-11784
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)N10210125
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• 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: 12/20/2021
• 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: N10210125 0093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2021
• 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.
• Patient Age: 61 YR
• Patient Sex: Male