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

Model Number 470530-08

Device Problems Difficult to Open or Close (2921); Mechanical Jam (2983)

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

Event Date 11/20/2020

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.The customer reported complaint was confirmed but not replicated.Failure analysis found the primary failure of shifting failure to be related to the customer reported complaint.Based on the log review, the curved-tip stapler 30 instrument was found to have a shifting failure, which indicated that the shifting failure happened after initialization and occurred when the instrument was shifting to clamp from roll.The shifting failure was triggered as the instrument initiated the clamp, so tissue likely would have been between the jaws, but the instrument was not yet clamped, replicating the customer reported message.However, the shifting failure was not replicated during in-house testing.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The jaws opened and closed properly.The instrument clamped, fired, and unclamped successfully.The instrument was fired with a white 30 reload and no malformed staples were observed.The visual inspection was performed and no damage was observed.The root cause of this failure is not determinable.Additional finding not reported by site: the instrument was found to have a reload recognition failure based on log review.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.System logs showed that the instrument was last used on system number (b)(4) on (b)(6) 2020 and it had 15 lives remaining.A review of the stapler log was conducted by an isi failure analysis engineer (fae).The following additional information was provided: logs showed that there was a shifting failure related with this curved-tip stapler 30 instrument.The shifting failure would prompt a message to the user indicating the irk may be needed.In this case the shifting failure occurred as the instrument was shifting to initiate the clamp sequence, so the instrument was not yet clamped.Based on the information provided at this time, this complaint is being reported because curved-tip stapler 30 instrument had clamping issues.Failure analysis confirmed that a shifting failure mode happened after initialization which could prevent unclamping of the instrument jaws.While there was no harm or injury to the patient and the procedure was completed with no further reported issues, 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 pulmonary lobectomy surgical procedure, the curved-tip stapler 30 had clamping issue.The instrument release kit (irk) was used.The procedure was completed with no reported injury.Intuitive surgical inc, (isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• 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: 11089130
• MDR Text Key: 240032163
• Report Number: 2955842-2020-11413
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112717
• UDI-Public: (01)00886874112717(10)T10190314
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/04/2020

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: 470530-08
• Device Catalogue Number: 470530
• Device Lot Number: T10190314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1