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

Model Number 470298-14

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

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

Event Date 11/09/2020

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 investigations confirmed but did not replicate the customer reported complaint "the stapler release kit (srk) had to be used to remove from the bowel".Failure analysis found the primary failure of failed unclamp to be related to the customer reported complaint.The instrument was found to have an unclamp failure based on log review.Additional findings not related to the customer reported complaint: the instrument was found to have repeated clamping failures based on log review.The instrument passed an in-house shim test.The instrument was found to have a low range of motion (rom) homing failure during in-house testing.After using the unjamming tool on the instrument, the instrument was placed and driven on an in-house system.The instrument passed initialization and 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.The stapler reload used during this event was returned to isi for evaluation.Failure analysis investigation has been completed.The reload was returned unused and no damage was found.The stapler sheath used during this event was returned to isi for evaluation.Failure analysis investigation has been completed.The sheath was found to have no tears or physical damage.A review of the site's complaint history identified no other reportable complaints for this product.A review of system logs for system (b)(4) with a procedure date of (b)(6)2020, confirmed a stapler 45 (pn # 470298-14 / lot # t10200716 - 0015) was exchanged with another stapler 45 (pn # 470298-14 / lot # t10191011- 0082) during this procedure.The instrument has a maximum of 50 uses.There are 46 more uses remaining.No image or video clip for the reported event was submitted for review.The isi tse found logs show errors 22030, 256.Error 22030- a stapler 45 failed in its operation - failure mode: unclamping failure / general failure stapler 45 / sn:(b)(4).Emergency stop button was pressed by a user on surgeon side console (ssc1).Core dump associated with error 256.The 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 classified as a reportable event due to the following conclusion: site reported they had a stapler 45 stuck on tissue.The stapler failed to release from tissue when commanded by the user or system.An srk was used to release the stapler from tissue.Although there was no report of patient harm, injury or adverse outcome due to the event, if it were to recur the patient may require additional surgical intervention such as cutting of tissue.At this time, it is unknown what caused the unclamping issue to occur.

Event Description

It was reported that during a da vinci-assisted low anterior resection surgical procedure, the site called in to report that they had a stapler 45 stuck on tissue.Onsite logs show errors 22030, 256.Staff stated they were using a stapler 45 with a green reload.The intuitive surgical, inc.(isi) technical support engineer (tse) walked staff through using the stapler release kit (srk) tool to manually open the jaws from the bowel tissue and they were successful.Staff installed another stapler 45 and it worked normally.The tse instructed staff to rma the stapler and the reload.Staff proceeded with the case.The procedure was completed with a back-up stapler with no reported injury.Isi followed up with the isi senior clinical sales representative and obtained the following additional information: the 45 stapler would not clamp on tissue during the procedure.After several attempts the stapler did not release from the tissue and the emergency release tool was used to open the jaws of the stapler.The surgeon never fired the stapler.A new 45 stapler was introduced and completed the task.No patient harm was reported.Additional information received from da vinci coordinator: the stapler was inspected prior to use.The surgeon did not encounter any obstructions such as clips, staples, or other hard material between the instrument jaws.Patient tissue was normal.There was no tissue tension or tissue bunching.No patient harm was reported.

• 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: 10939486
• MDR Text Key: 252965899
• Report Number: 2955842-2020-11293
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112427
• UDI-Public: (01)00886874112427(10)T10200716
• 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: health professional,other
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/09/2020

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: 470298-14
• Device Catalogue Number: 470298
• Device Lot Number: T10200716 0015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2020
• 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: 54 YR
• Patient Weight: 83