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

Model Number 471205-17

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Insufficient Information (4580)

Event Date 10/02/2023

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The fenestrated bipolar forceps instrument was analyzed and found the primary failure of broken grip cable to be related to the customer reported complaint.The instrument was found to have a broken grip cable at the proximal end.This causes the grasper not to function properly.Additional observation related to customer reported complaint: the instrument was found to have a loose pitch cable at the distal end.The loose pitch cable at the distal end was caused by the broken pitch cable on the proximal end.In addition, the instrument was found to have charring and/or localized melting on the outer surface of one bipolar yaw pulley, resulting in an exposed electrode.The instrument passed the electrical continuity test.The complaint was confirmed by failure analysis.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the fenestrated bipolar forceps instrument's graspers would not function properly.The procedure was completed with no injury to the patient.

Manufacturer Narrative

The fenestrated bipolar forceps instrument was further evaluated, and it was found to have a broken proximal pitch cable at the proximal end.This causes the grasper not to function properly.Additionally, the instrument was found to have charring and/or localized melting on the outer surface of one bipolar yaw pulley, resulting in an exposed electrode.The instrument passed the electrical continuity test.

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: 18610747
• MDR Text Key: 334126530
• Report Number: 2955842-2024-10414
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(11)230706(10)K10230706(91)0003
• 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: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• 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: K10230706 0650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2023
• 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