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

Model Number 471205-17

Device Problems Break (1069); Fracture (1260)

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

Event Date 12/22/2021

Event Type  malfunction  

Event Description

It was reported that during central processing, the fenestrated bipolar forceps instrument had a frayed cable.There was no report of patient involvement.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument and performed a device evaluation.Failure analysis confirmed the customer reported issue.Failure analysis found the instrument had a broken main tube extension.The main tube breakage was observed to be where the main tube extension meets the proximal clevis at the distal end.A broken piece was not returned, measuring roughly 0.25" x 0.04¿ in size.Instrument main tube extension breakages are typically attributed to mishandling/misuse.The following was found during the device evaluation, but is not related to the reportable finding: the instrument was found to have a broken conductor wire at the wrist.The instrument failed the electrical continuity test.No signs of thermal damage or loss of conductor wire insulation were observed.Root cause of broken conductor wire is attributed to a component failure.No functional test for energy activation could be performed due to the wire breakage.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the device logs for the fenestrated bipolar forceps (part# 471205-17| lot-sequence# n14200622- 0086) associated with this event has been performed.Per this review of the logs, the fenestrated bipolar forceps was last used on (b)(6) 2021 during a colon resection on system serial# (b)(4).No image or video clip for the reported event was submitted for review.This complaint is being reported because failure analysis identified a fragment was missing from a portion of the device that enters the patient.Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no harm or injury to patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.

• 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: 13595805
• MDR Text Key: 288189367
• Report Number: 2955842-2022-10347
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)N14200622
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• 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: N14200622 0086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2020
• 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