• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTUITIVE SURGICAL, INC ENDOWRIST CURVED-TIP STAPLER 30 Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameENDOWRIST
Type of DeviceCURVED-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 Key10882070
MDR Text Key252280408
Report Number2955842-2020-11235
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K152421
Number of Events Reported1
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 Received11/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470530-08
Device Catalogue Number470530
Device Lot NumberT10190829
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/29/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-