MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; SMALL GRASPING RETRACTOR

Model Number 470318-10

Device Problem Defective Device (2588)

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

Event Date 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

The small grasping retractor instrument has been returned and evaluated by the failure analysis team.Failure analysis investigations replicated/confirmed the customer reported complaint of "physical damage." failure analysis found the primary failure of broken pitch cable to be related to the customer reported complaint.For clarification, the instrument was found to have a broken pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was missing from the clevis.Pitch cable breakage occurs when tensile load exceeds the ultimate strength of the material.The pitch cable construction is designed to optimize load and fatigue (cycling) characteristics.Variation in customer use conditions, procedure type, patient anatomy, product handling, instrument tip lengths, grip torque and manufacturing tolerances are a few variables which can influence pitch cable failure.The root cause of this failure was attributed to a component failure and related to device design.A review of the site's complaint history does not reveal any related complaints involving this product or this event.No image or procedure video was provided for review.A review of the instrument log for the small grasping retractor instrument (470318-10/n10210503 0048) associated with this event has been performed.Per the logs, the instrument was last used on (b)(6) 2021.This complaint is being reported based on the following conclusion: this instrument is designed with two pitch cables, each with a crimp at the distal end.If a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall into the patient.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 missing patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.

Event Description

It was reported that during central processing, the small grasping retractor was identified to be broken.There was no report of patient involvement.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: central processing noticed the broken instrument.The reporter had no further details or information to provide.

• Brand Name: ENDOWRIST
• Type of Device: SMALL GRASPING RETRACTOR
• 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: 13041140
• MDR Text Key: 290149597
• Report Number: 2955842-2021-11777
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112441
• UDI-Public: (01)00886874112441(11)210429(10)N10210503
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/22/2021

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: 470318-10
• Device Catalogue Number: 470318
• Device Lot Number: N10210503 0048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2021
• 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.