MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST TIP-UP FENESTRATED GRASPER

Model Number 470347-12

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 01/10/2022

Event Type  malfunction  

Event Description

It was reported that during central processing, the tip-up fenestrated grasper had a damaged shaft/tube. There was no report of patient involvement.

Manufacturer Narrative

Intuitive surgical, inc. (isi) received the instrument involved with this complaint and completed the device evaluation. Failure analysis (fa) confirmed the reported complaint. Failure analysis found the primary failure of scratches on the main tube to be related to the customer reported complaint. The instrument was found to have various scratch marks with light material removed on the main tube. The scratch marks were 0. 096¿ - 0. 274" in length and were not aligned with the tube axis. The root cause of scratch marks /abrasions instrument main tube is typically attributed to the mishandling/misuse such as excessive contact with abrasive or hard surfaces during transport or reprocessing. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. No image or procedure video was provided for review. A review of the instrument log for the tip-up fenestrated grasper (part# 470347-12 / lot# u10210804/ sequence# 0024) associated with this event has been performed. Per this review of the logs, the instrument was last used on (b)(6) 2022 on system serial# (b)(4) with 3 uses remaining. Based on this review, the instrument was not used in subsequent procedure(s) after the alleged event. There was no image or video clip submitted for review. This complaint is considered a reportable event due to the following conclusion: failure analysis acknowledges that 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 report of harm or injury to the patient and no report of fragments falling into the patient, the reported failure mode could likely cause or contribute to an adverse event if the fragment(s) did fall into the patient.

• Brand Name: ENDOWRIST
• Type of Device: TIP-UP FENESTRATED GRASPER
• 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: 13719464
• MDR Text Key: 286922223
• Report Number: 2955842-2022-10559
• Device Sequence Number: 1
• Product Code: NAY
• 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: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 470347-12
• Device Catalogue Number: 470347
• Device Lot Number: U10210804 0024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2021
• 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 Treatment Data

Date Received: 03/10/2022 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES