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

Model Number 480460-09

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not yet received the sureform stapler 60 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 the product is returned and evaluated and/ or if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product.No image or video clip for the reported event was submitted for review.A review of the system logs for sureform stapler 60 (part # 480460-09 /lot # t92210920-0198) was performed.The device was last used on 03-feb-2022 during a procedure performed on system sk4746.The device had 11 uses remaining.An isi failure analysis engineer (fae) reviewed logs.Logs showed that sureform stapler 60 part number 480460-09, lot t92210920-0198 was installed twice during the procedure.The stapler fired one reload (white) on its first install and was completed with 1 pause for compression.There were no incomplete clamps by this instrument.The second install used a green reload, and the instrument did not attempt any clamps or fires.Logs show that the system detected the use of the manual release knob (mrk) on this instrument during this second install via error code 22027.The use of the mrk caused the system to force expire the instrument, which is by design.This is also shown in the logs via error 282.This complaint is being reported due to the following conclusion: during a da vinci- assisted surgical procedure, 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

It was reported that during a da vinci-assisted sigmoid colectomy surgical procedure, the sureform stapler 60 wouldn't open.The customer was using a green reload when the issue occurred.The target tissue was colon and the customer indicated there was no obstructions between the instrument jaws.The customer replaced the instrument with a spare sureform stapler 60 instrument.The procedure was continued as planned and there was no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer confirmed that the stapler was inspected prior to the procedure and no issues were identified.The stapler had also been deployed successfully during the procedure prior to the reported event.There was no error logged in the system at the moment when the jaws didn¿t open.It was reported that the instrument was replaced with a spare sureform stapler 60 and the procedure was completed as planned with no reported injury.The customer was unsure how the stapler was removed but confirmed there was no adverse effect to the grasped tissue.The customer indicated that at the time of the event the surgeon noted that the instrument was not responding to movements of the master tool manipulator.

• 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: 13664517
• MDR Text Key: 289256373
• Report Number: 2955842-2022-10452
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 10886874115647
• UDI-Public: (01)10886874115647(10)T92210920
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: T92210920 0198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2022
• Initial Date FDA Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 60 YR
• Patient Sex: Female