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

Model Number 470318-10

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/24/2021

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted sigmoid colectomy surgical procedure, the steel cable of the small grasping retractor broke.A similar backup da vinci instrument was used to continue with the case.The procedure was completed with no reported injury.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the small grasping retractor instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the customer reported complaint.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 clevis hub.The broken cable segment that contains the crimp was missing from 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 was determined to be a component failure and related to device design.A log review was performed for the small grasping retractor instrument reported in this complaint (pn: 470318-10/n2101110043) and the following was found: the instrument was last used on (b)(6) 2021.The instrument had 8 uses remaining and was not used for any subsequent procedures.There was no photo or video provided by the site for review.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: 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 inside the patient.Although there was no patient injury, the product malfunction could cause or contribute to an adverse event if the failure were to recur.

• 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: 13101629
• MDR Text Key: 288672030
• Report Number: 2955842-2021-11823
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112441
• UDI-Public: (01)00886874112441(11)210107(10)N10210111
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• 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: N10210111 0043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2021
• 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: 82 YR
• Patient Sex: Female