MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; FORCE BIPOLAR

Model Number 471405-06

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 09/05/2023

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted myomectomy surgical procedure, the force bipolar instrument was working properly until the surgeon attempted to remove it from the trocar.At that time, it was noted that the articulating joint at the working end of the instrument had slipped out of track and became stuck on the trocar sleeve as it was withdrawn.The customer then removed the trocar with the force bipolar instrument.After removing them from the patient' body, the customer still found it difficult to remove the instrument from the trocar.The surgeon informed that this issue has been happening with some frequency.No other information was available.Intuitive surgical, inc.(isi) has attempted to obtain additional information related to the reported event.However, no further details have been received as of the date of this report.

Manufacturer Narrative

An investigation is in progress to determine the cause of this reported event.A return material authorization (rma) was issued to the customer requesting to have the intuitive device returned.However, isi has not received the product involved with the alleged issue to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.A follow-up mdr will be submitted if the product is returned (post failure analysis evaluation) or if additional information is received.

Manufacturer Narrative

A review of the provided image was performed by an intuitive surgical, inc.(isi) failure analysis engineer.The following additional information was provided: it¿s a bit difficult to tell but it looks like the grip may be bent at the base.There doesn¿t appear to be any other damage.Isi followed up with the initial reporter, but the customer was not able to provide further details.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: FORCE BIPOLAR
• 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: 17821916
• MDR Text Key: 324334783
• Report Number: 2955842-2023-18765
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)K11230122
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K214095
• 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: 09/05/2023

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: 471405-06
• Device Catalogue Number: 471405
• Device Lot Number: K11230122 0007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/05/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 09/27/2023
• Supplement Dates FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2023
• 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
• Patient Sex: Female