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

Model Number 471205-17

Device Problem Material Separation (1562)

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

Event Date 01/11/2024

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted inguinal hernia - unilateral surgical procedure, the fenestrated bipolar forceps instrument insulation on the wire was observed.The procedure was completed as planned with no reported injury.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the fenestrated bipolar forceps instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.

Event Description

Refer to h10/h11 for follow-up information.

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 to have a broken conductor wire between the wire crimp on the grip and the silicone potting sealing the wire entrance to the yaw pulley.The instrument failed the electrical continuity test.The wire was fully broken, and the conductor wires were exposed.No signs of thermal damage were observed.Components adjacent to the broken wire do not show damage.The complaint was confirmed by failure analysis.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Failure analysis investigations confirmed the customer reported complaint.The instrument was found to have the conductor wire broken within the bipolar yaw pulley, between the wire crimp on the grip and the silicon potting sealing the wire entrance to the yaw pulley.The wire was fully broken, and the conductor wires were exposed.The other end of the broken wire was found to still be attached within the yaw pulley, indicating that the break was not a result of a crimping failure.The instrument failed the electrical continuity test.The instrument has four remaining uses out of 14.The conductor wire insulation did not exhibit any damage.

• 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: 18681562
• MDR Text Key: 335450321
• Report Number: 2955842-2024-11221
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K214095
• 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: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• 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: K12230720 0138
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2023
• 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