MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; TIP-UP FENESTRATED GRASPER

Model Number 470347-12

Device Problem Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the customer called an intuitive surgical inc.(isi) technical support engineer (tse) to report that part of the lung was caught on the instrument while using.The tissue caught on the joint between the arm and grasper.There was no reported injury.On 26-may-2022, intuitive surgical, inc.(isi) received userfacility report #0700220000-2022-8125 stating: "part of lung tissue caught on instrument while using.Tissue caught on joint between arm and grasper." 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.

Manufacturer Narrative

Isi has not received the tip-up fenestrated grasper for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if additional information is obtained.No image or procedure video was provided for review.A review of the device logs for the tip-up fenestrated grasper (470347-12/u13210604-0046) associated with this event has been performed.Per this review of the logs, the tip-up fenestrated grasper was last used on (b)(6) 2022 via system sk0877.There were 5 uses remaining after this last usage.This last usage of the device was before the reported event date, indicating that the device did not pass recognition or the issue was identified before installation on the reported event date.This complaint is being classified as a reportable event due to the following conclusion: it was reported that tissue got caught on the joint between the arm and grasper.Medical intervention may be required in the event that a moving instrument mechanism within an instrument entraps tissue and causes damage.At this time, it is unknown what caused the device entrapment issue to occur.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.

• Brand Name: ENDOWRIST
• Type of Device: TIP-UP FENESTRATED GRASPER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 14813975
• MDR Text Key: 303234929
• Report Number: 2955842-2022-12424
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112496
• UDI-Public: (01)00886874112496(11)210604(10)U13210604
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470347-12
• Device Catalogue Number: 470347
• Device Lot Number: U13210604 0046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• 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
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES