MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER 45

Model Number 470298-11

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

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

Event Date 05/28/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the stapler 45 instrument involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the issue through error logs.Review of logs confirmed clamping, unclamping, and jammed mechanism failures, but the failures were not replicated during in-house testing.The instrument was placed and driven on an in-house system.The instrument failed initialization, so an unjamming tool was used.The instrument then passed initialization and engagement.The instrument clamped, fired, and unclamped successfully.A review of the log shows that the jammed mechanism error is likely due to the instrument's failure to unclamp.A log review was performed for the stapler 45 instrument reported in this complaint (pn: 470298-11/t101806060030) and the following was found: the instrument was last used on (b)(6) 2020 on (b)(4).The instrument had 34 uses remaining and was not used for any subsequent procedures.No photo or video was provided by the site for review.A review of the site's complaint history does not show any additional complaints related to this product.This complaint is being reported because a stapler instrument was unable to unclamp or incurred a failure mode that is known to prevent unclamping of the instrument jaws.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 low anterior resection surgical procedure, the customer stated that the stapler 45 instrument was unable to clamp with the green reload.The system was locked and displayed a message to remove the instrument manually.The customer used the emergency release kit until step two and then they were able to remove the instrument, but the system no longer recognized the stapler 45 instrument.It was noted that the patient¿s tissue was too thick.A backup instrument was used to proceed with the surgery.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST
• Type of Device: STAPLER 45
• 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: 10486702
• MDR Text Key: 233927224
• Report Number: 2955842-2020-10854
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112427
• UDI-Public: (01)00886874112427(10)T10180606
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K140553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/10/2020

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: 470298-11
• Device Catalogue Number: 470298
• Device Lot Number: T10180606 0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2018
• 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