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 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

Isi received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed but did not replicate the customer reported complaint.The instrument was found to have an unclamp failure and jammed mechanism homing failures based on log review.In addition, the instrument was found to have a low range of motion (rom) homing failure based on log review.The instrument was installed on an in-house system and passed the initialization test.The instrument clamped and fired successfully.A review of the instrument log for the stapler 45 instrument associated with this event confirmed that the instrument was last used on (b)(6) 2020 on system (b)(4).Per logs, the instrument has 10 uses remaining.A review of the site's complaint history identified no other reportable complaints for this product.No image or video clip for the reported event was submitted for review.The intuitive surgical endowrist stapler 45, stapler 45 reloads, and other stapler accessories (including the bladeless obturators) are intended to be used with a compatible da vinci surgical system for resection, transection and/or creation of anastomoses in general, thoracic, gynecologic and urologic surgery.The device can be used with staple line or tissue buttressing material (natural or synthetic).Based on the information provided at this time, 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 sigmoid colectomy surgical procedure, the stapler 45 instrument "clamping sequence initiated but failed to release".The customer reportedly had to use the key to release the stapler 45 instrument.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the procedure was delayed by 1 hour.The patient's tissue was safely removed using the stapler release kit (srk).There was no adverse effect to the grasped tissue and no injury occurred to the patient.The patient is a (b)(6) year old female.The customer could not provide the patient's race, ethnicity, and weight nor information about the patient medical history.

• 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: 10434961
• MDR Text Key: 238136818
• Report Number: 2955842-2020-10769
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112427
• UDI-Public: (01)00886874112427(10)S14160606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/29/2020

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: S14160606 0017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2016
• 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
• Patient Age: 62 YR