MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MONOPOLAR CURVED SCISSORS

Model Number 470179

Device Problem Difficult to Remove (1528)

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

Event Date 08/18/2023

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted surgical procedure an specified instrument was stuck on the trocar.The customer received phone assistance from the technical support engineer (tse).User inquired about usage of an instrument release kit (irk).Tse informed the user that irk is applied if instrument is grasping a tissue and it is used to release the jaws.It was confirmed that the instrument was not grasping tissue and it was further confirmed that the instrument was removed.The user continued the procedure with no further issue reported.No fragment fell into the patient.No known impact or patient consequence was reported.

Manufacturer Narrative

An investigation was completed to determine the cause of this reported event.Attempts have been made to obtain additional information from the customer concerning the reported event with no success.This complaint will be classified based on the provided information at this time. 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 instrument is returned (post failure analysis evaluation) or if additional information is received.

• Brand Name: ENDOWRIST
• Type of Device: MONOPOLAR CURVED SCISSORS
• 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: 17761378
• MDR Text Key: 323754565
• Report Number: 2955842-2023-18497
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220023
• 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: 08/18/2023

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: 470179
• Device Catalogue Number: 470179
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES