MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MEDIUM-LARGE CLIP APPLIER

Model Number 470327-12

Device Problems Material Separation (1562); Difficult to Open or Close (2921)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/08/2024

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted surgical procedure, the clip from the medium-large clip applier (mlca) instrument was not attached firmly and fell inside the patient's peritoneal cavity.The procedure was being completed as planned.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the clip was retrieved during the same procedure.The clip was discarded and will not be returned.

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive the instrument involved with this complaint, however failure analysis investigations have not been completed.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted after the product is evaluated and/or if additional information is received.A review of the provided image was performed by an isi failure analysis engineer, and the following additional information was provided: no damage to the instrument was observed.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the medium-large clip applier instrument involved with this complaint and completed the device evaluation.Failure analysis did not replicate nor confirm the reported complaint.Visual inspection did not reveal any damage.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.The instrument passed the clip test.The instrument was fully functional.No product issue was identified.

• Brand Name: ENDOWRIST
• Type of Device: MEDIUM-LARGE CLIP APPLIER
• 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: 18889909
• MDR Text Key: 337509562
• Report Number: 2955842-2024-12141
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112465
• UDI-Public: (01)00886874112465(11)221014(10)K11221016
• 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: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470327-12
• Device Catalogue Number: 470327
• Device Lot Number: K11221016 0078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/14/2022
• 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