MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; SUCTION IRRIGATOR

Model Number 480299-06

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 02/14/2024

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the suction irrigator was difficult to take out.The instrument tip was bent and would not straighten.The surgeon had to extend the incision and use a clamp to take the bent tip off the shaft of irrigator.All pieces were accounted for, and nothing fell inside the patient.The procedure was completed.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the surgeon articulated the suction irrigator tip to use it but it would not respond when he tried to straighten it.The cannula had to be removed with the suction irrigator.The instrument was inspected prior to use and no damage out of the ordinary was noted.The surgical task was for irrigating and suctioning after gallbladder was taken off the liver bed.The instrument did not collide with any other instrument or tool during the procedure.The instrument cleaning or sterilization methods did not change.The patient had to have a bigger incision than usual to remove the instrument.

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The instrument was found to have the snake wrist broken at the distal end.Two sections (female - female wrist disk, and end cap wrist disk) of the snake wrist were not returned with the instrument.The complaint was confirmed by failure analysis.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.

• Brand Name: ENDOWRIST
• Type of Device: SUCTION IRRIGATOR
• 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: 18880444
• MDR Text Key: 337406725
• Report Number: 2955842-2024-12201
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874114817
• UDI-Public: (01)10886874114817(10)K15230831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162973
• 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
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480299-06
• Device Catalogue Number: 480299
• Device Lot Number: K15230831 0255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2024
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 128 KG
• Patient Ethnicity: Hispanic
• Patient Race: White