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 Insufficient Information (4580)

Event Date 10/17/2023

Event Type  Injury  

Manufacturer Narrative

A return material authorization (rma) was issued to the customer requesting to have the intuitive surgical, inc.(isi) device returned.As of the date of this report, the product has not yet been received.

Event Description

It was reported that during a da vinci-assisted rectopexy surgical procedure, the suction irrigator broke and was unable to be removed from port.The procedure was completed as planned.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to starting and no damage was identified.It is unknown how the instrument was removed and if the incident involved any fragment falling into patient.The procedure was completed by using a backup instrument.There was a delay of 5 minutes.It is unknown if any tests were performed to search for fragments that may have fallen inside the patient.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) contacted the product complaints coordinator and obtained the following information: nothing was broken off the distal tip of the suction irrigator instrument.No fragments landed in the patient.No follow up imaging was required to locate fragments.

• 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: 18172103
• MDR Text Key: 328554215
• Report Number: 2955842-2023-20319
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874114817
• UDI-Public: (01)10886874114817(17)250630(10)K15230615
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K162973
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

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: K15230615
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 10/25/2023
• Supplement Dates FDA Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2023
• Is the Device Single Use?: Yes
• 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