MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MEGA NEEDLE DRIVER

Model Number 470194-08

Device Problem Insufficient Information (3190)

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

Event Date 12/19/2023

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.Analysis is in progress.A follow-up mdr will be submitted when the instrument is evaluated and/ or if additional information is received.

Event Description

It was reported that prior to starting a da vinci-assisted surgical procedure, the mega needle driver instrument "clicks" at the pivot point of the driver and the pin appears to be loose.The procedure was completed.

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The mega needle driver instrument was analyzed, and the complaint was not confirmed by failure analysis.A visual inspection displayed no signs of physical damage.The grip pin was not loose and there was no clicking observed.The instrument was placed on an in-house system.The instrument failed engagement tests on 3 of the attempts.The instrument was not fully functional.Additional observation(s) not reported by site: the instrument failed mechanical engagement when placed in the system.Instrument inputs failed to engage with the sterile adapter on 3 out of 3 attempts.The system displayed error code "22020" which confirms an engagement error.The instrument was found to have a loose pitch cable at the proximal end.A visual inspection displayed no signs of physical damage internal or external.There was a loose screw inside of the housing.The instrument was found to have a loose screw inside of the housing.The screw was loose on the pitch clamping pulley.As a result, the cables were slightly loose which caused the instrument to fail engagement.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: MEGA NEEDLE DRIVER
• 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: 18481569
• MDR Text Key: 332977245
• Report Number: 2955842-2024-10181
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112342
• UDI-Public: (01)00886874112342(11)230810(10)K10230810(91)0005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

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: 470194-08
• Device Catalogue Number: 470194
• Device Lot Number: K10230810 0322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2023
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 02/06/2024
• 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.