MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; STAPLER 60

Model Number 480460-09

Device Problems Failure to Form Staple (2579); Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 02/14/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted procedure the customer had issues with the stapler malfunction leading to use the emergency release.The procedure was aborted to another da vinci system.Intuitive surgical, inc.(isi) followed up with the customer and the customer could not provide additional information on the specific stapler.No patient demographic information available.

Manufacturer Narrative

The sureform 60 stapler instrument has not been returned for evaluation; therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.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.System log review confirmed that the sureform 60 stapler was used on (b)(6) 2022 with 7 uses remaining on (b)(4).This complaint is considered a reportable event due to the following conclusion: it was alleged that the sureform stapler failed to unclamp.Medical intervention may be required in the event that the stapler fails to unclamp from tissue when commanded by the user or system.At this time, it is unknown what caused the unclamping event to occur.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.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

A review of the advanced stapler log review for the sureform stapler 60 associated with this event has been performed by an intuitive surgical, inc.(isi) fae.The following additional information was provided: a log review was performed and showed that pn 480460-09, lot l90210119-0150 was installed 5x and fired 5 reloads (1 green followed by 4 blue).All firings were completed per the logs.Firing #2 had 1 pause for compression, the rest had no pauses.Following the 5th firing, the subsequent unclamp attempt failed.Msc logs confirm the unclamp failure and show e-stop button was pressed a couple times after the unclamp failure.Following the 2nd e-stop press, the msc logs show that the system detected use of the manual release knob, and the system force expired the instrument (as expected when the manual release knob (mrk) use is detected).

• Brand Name: SUREFORM
• Type of Device: STAPLER 60
• 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: 13983489
• MDR Text Key: 298169660
• Report Number: 2955842-2022-10851
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115647
• UDI-Public: (01)10886874115647(10)L93211123
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480460-09
• Device Catalogue Number: 480460
• Device Lot Number: L90210119 0150
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: ISIFA2022-02-C
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES