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 12/17/2020

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted surgical procedure, the tip-up in arm 1 was abnormal.The tip of the instrument appeared to have come off the plastic sheath and was now bent at a 90 degree angle and the instrument was not able to be removed through the port.The instrument was reportedly inspected prior to use, and no issues were noted.The surgeon did not notice any issues with the functionality of the instrument during the surgical procedure.The customer denied that the instrument made contact with any other instrument or hard material during the surgical procedure.It was confirmed no fragment fell inside the patient.There was no patient harm, injury or adverse outcome due to the alleged product issue.

Manufacturer Narrative

The tip-up fenestrated grasper instrument was returned and failure analysis found the instrument main tube broken.A piece measuring approximately 0.159 x 0.347 was not returned with the instrument.

• 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: 17038568
• MDR Text Key: 316348546
• Report Number: 2955842-2023-15371
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112496
• UDI-Public: (01)00886874112496(10)N10190902
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/17/2020

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: 470347-11
• Device Catalogue Number: 470347
• Device Lot Number: N10190902 0098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES