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 03/29/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the sureform60 stapler associated with the complaint.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 and/or this event.A review of the instrument log for part# 480460-09/lot#t94220104 0049 associated with this event has been performed.Per logs, the sureform60 stapler was last used on (b)(6) 2022 on system (b)(4) with 8 lives remaining.No investigation required as no image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: it was alleged that the sureform 60 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 gastric bypass surgical procedure, the sureform 60 stapler did not open.No known impact or patient consequence was reported.Per subsequent follow-up, the reporter confirmed and clarified that when the sureform 60 stapler entered in the patient, the surgeon could not open it.The stapler did not function at all; it was not stuck on tissue.A backup stapler was used to proceed with the surgical task.The procedure was completed without harm or injury to the patient.No other information was provided.

Manufacturer Narrative

Corrected information can be found in fields h7 and h9.Field action information was added.

Event Description

Refer to h10/h11 for follow-up information.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Additional information can be found in d9, g3, g6, h2, and h3 evaluation information can be found in h6, and h10 intuitive has received the sureform 60 stapler instrument associated with this complaint and completed investigations.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.A review of the log did not show any clamping or unclamping failures.Additionally, the instrument was found to have failed the engagement test based on log review and during in-house testing.The instrument was placed on an in-house system with an in-house drape and seal.The instrument failed the engagement test.The engagement test was performed a total of three times.It passed the first and second engagement tests but failed the third time.The root cause was not determinable/applicable.Moreover, the instrument was found to have roll friction of the main tube.Friction is observed when manually rotating the main tube.Signs of corrosion were found on the instrument bearing.Bearing found at the proximal end of the main tube exhibits orange discoloration.Corroded metal shavings were found stuck to the magnet.Root cause of this failure is attributed mishandling/misuse.

Manufacturer Narrative

The sureform 60 stapler instrument was placed on an in-house system for functional testing.The sureform 60 stapler instrument was able to open/close jaws with no issues and complete a firing on test foam using a green reload.Reported complaint was unable to be replicated.Regarding the roll friction and corroded bearing observation, the friction is likely caused by the corroded bearing.However, the bearing corrosion likely occurred during transit, and likely was not present during the procedure.Root cause of bearing corrosion is transport/storage related.

• 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: 14247542
• MDR Text Key: 299401854
• Report Number: 2955842-2022-11310
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115647
• UDI-Public: (01)10886874115647(10)T94220104
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K173721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• 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: T94220104 0049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2022
• 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.