MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST CURVED-TIP STAPLER 30

Model Number 470530-08

Device Problems Entrapment of Device (1212); Firing Problem (4011)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc. (isi) received the curved-tip stapler 30 instrument involved with this complaint and completed the device evaluation. Failure analysis investigation confirmed the customer reported complaint. The instrument was found to have a firing failure based on log review. The instrument was placed and driven on an in-house system. The instrument passed initialization. The instrument moved intuitively with full range of motion in all directions. The jaw opened and closed properly. The instrument clamped, fired and unclamped without any issues. Product and event verification: a review of the device logs for the curved-tip stapler 30 instrument (part# 470530-08 | lot/serial# (b)(4)) associated with this event has been performed. Per this review of the logs, the curved-tip stapler 30 instrument was last used on 12-oct-2020 via system serial# (b)(4). There were 14 uses remaining after this last usage. No error would appear in the logs for this type of reported issue. No photo or video was provided by the site for review. This complaint is being reported due to the following conclusion: it was reported that during a da vinci-assisted pulmonary lobectomy procedure, the staples did not release from the reload pocket despite forming in sections of the reload where tissue was intended to be stapled. Although no patient harm occurred, if this malfunction were to recur it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the customer stated that the reloads were accumulated in the joint and they were unable to fire the curved-tip stapler 30 instrument. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) attempted to obtain further information related to the event by following up with the customer. However, as of the date of this event, no additional details have been received.

• Brand Name: ENDOWRIST
• Type of Device: CURVED-TIP STAPLER 30
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10882070
• MDR Text Key: 252280408
• Report Number: 2955842-2020-11235
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K152421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 470530-08
• Device Catalogue Number: 470530
• Device Lot Number: T10190829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse