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

Model Number 470347-11

Device Problems Difficult to Remove (1528); Material Twisted/Bent (2981)

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

Event Date 01/19/2024

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the tip-up fenestrated grasper had become stuck at the cannula tip.The customer was able to remove the instrument along with the cannula simultaneously but was unable to remove due to tip being bent.A technical service engineer (tse) advised to straighten the tip with the hospital own tools.Therefore, the customer used pliers to straighten the problem area and remove the tip-fenestrated grasper from the cannula.The procedure was completing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up and obtained the following additional information: the surgeon was able to confirm that there were no fragments upon visual inspection.No post-operative test was performed.The patient has not returned to the hospital due to experiencing any post-surgical complications due to retaining a foreign object.The procedure was completed robotically with no patient injury or harm.

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The tip-up fenestrated grasper (tufg) instrument was analyzed and found to have the main tube broken at the distal end.No material was found missing.Further investigation found fragments inside the main tube.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.A review of the submitted image was performed and the following additional information was provided: the image shows the tip-up fenestrated grasper instrument tip with no obvious damage.

• 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: 18823223
• MDR Text Key: 337072342
• Report Number: 2955842-2024-12025
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/14/2024

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: 470347-11
• Device Catalogue Number: 470347
• Device Lot Number: K11230810 0194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2023
• 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