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

Model Number 470318-10

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted surgical procedure, the small grasping retractor instrument had a torn cable.There was no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter on 17-mar-2022 and obtained the following additional information: the site could not provide additional information about the reported complaint as the issue occurred a long time ago.The reporter was unable to provide the event date and it is unknown at this time.

Manufacturer Narrative

Isi has not received the small grasping retractor instrument 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 site's complaint history does not show any additional complaints related to this product and/or this event.Based on the information provided at this time, this complaint is being reported due to the following conclusion: it is unknown if a fragment fell 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 as unintended fragment(s) falling into the patient may require surgical intervention.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the small grasping retractor instrument involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the 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 still installed in the clevis.The root cause of a broken pitch cable is a component failure.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.A review of the instrument log for the instrument (pn 470318-10/lot # n10190407-0100) associated with this event was performed.Per logs, the instrument was last used on (b)(6) 2022 on system (b)(6) during a gastric bypass (roux-en-y) procedure.The instrument had four uses remaining after last use.

Event Description

Refer to h10/h11 for follow-up information.

• 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: 14096833
• MDR Text Key: 298668560
• Report Number: 2955842-2022-11017
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES