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

Model Number 471205-17

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 01/09/2024

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted surgical procedure, the fenestrated bipolar forceps instrument would not come out easily during exchange.It was indicated that the surgeon scrubbed back in to retrieve the instrument with a little force and inspection upon removal identified thermal damage on the instrument plastic tip piece.The procedure was completed with no reported injury.

Manufacturer Narrative

Isi has received the fenestrated bipolar forceps instrument; however, failure analysis is still ongoing.Additional information is being gathered to determine the contribution of the device to the customer reported issue.A follow-up mdr will be submitted post failure analysis evaluation.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument to perform failure analysis.The fenestrated bipolar forceps instrument was analyzed and found to have thermal damage on the yaw pulley.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument attached to and removed without any issues on three of three attempts.The instrument grips were manually manipulated, and the instrument passed an electric continuity test on three of three attempts.The instrument delivered very low energy on three of three attempts.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• 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: 18624074
• MDR Text Key: 334334098
• Report Number: 2955842-2024-10899
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)K12220314
• 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: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471205-17
• Device Catalogue Number: 471205
• Device Lot Number: K12220314 0267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• 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