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

Model Number 470430-06

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

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

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

Isi has not received the stapler 30 instrument involved with this complaint.Therefore the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if additional information is received.A log review was performed for the stapler 30 instrument reported in this complaint (pn: 470430-06/t101902040014) and the following was found: the instrument was last used on (b)(6) 2020 on (b)(4).The instrument had 48 uses remaining and was not used for any subsequent procedures.No error would appear in the logs for this type of reported issue.No photo or video was provided by the site for review.This complaint is being reported because a stapler instrument was unable to unclamp from tissue during a surgical procedure.The stapler release kit (srk) was used to successfully open the 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 surgical procedure, the customer was unable to open the stapler 30 instrument jaw.The customer used the stapler release kit (srk) to open the jaws and removed the reload.A backup instrument was used to proceed with the procedure.The procedure was completed with no reported injury.Intuitive surgical (is) contacted the site and obtained the following additional information regarding this event: the stapler instrument was not inspected prior to use.It worked during the surgical procedure and had been used for 1 hour before the issue occurred.The 4th stapler fire was involved with the reported event.No errors or messages were generated when the issue occurred.The surgeon did not encounter any obstructions such as clips, staples, or other hard material between the instrument jaws and no buttress material was used.There were no malformed staples.The target tissue was vessel which was the reason why the surgeon selected a white reload to perform the surgical task.The tissue was not calcified and was not exposed to any radiation or chemotherapy prior to the procedure.There was no tissue tension and no tissue bunching.

Manufacturer Narrative

4310, 61- intuitive surgical, inc.(isi) received the stapler 30 instrument involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the customer reported complaint but did not replicate it.The instrument was installed on an in-house system.The instrument passed the initialization test.The instrument clamped and fired successfully.Review of the log found that the last successful action that was taken by the instrument was a successful clamp confirming that the stapler release kit (srk) tool was used to remove the stuck reload.The instrument was transferred to engineering for further review.The logs does not show any roll brake errors.The logs do indicate that the last event performed by this instrument was a completed clamp without any corresponding unclamp.For an unknown reason, the user performed a clamp after having successfully fired and unclamped.This suggests the instrument was removed in a clamped state, which is considered misuse.The instrument was re-tested and performed clamping, firing, and unclamping as expected, suggesting the instrument was functioning properly.

• Brand Name: ENDOWRIST
• Type of Device: STAPLER 30
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10557431
• MDR Text Key: 240944557
• Report Number: 2955842-2020-10937
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112700
• UDI-Public: (01)00886874112700(10)T10190204
• Combination Product (y/n): N
• PMA/PMN Number: K152421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

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: 470430-06
• Device Catalogue Number: 470430
• Device Lot Number: T10190204 0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 09/25/2020
• Supplement Dates FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 32 YR