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

Model Number 470205-17

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 01/10/2024

Event Type  malfunction  

Event Description

It was reported that after a da vinci-assisted nephrectomy surgical procedure, the fenestrated bipolar forceps instrument had a melted insulation layer.The procedure was completed with no reports of patient injury.

Manufacturer Narrative

An intuitive surgical, inc.(isi) did receive a da vinci fenestrated bipolar forceps instrument to perform failure analysis.Failure analysis investigations confirmed the customer reported complaint.The instrument was found to have damage of the conductor wire¿s insulation.The conductor wire was found with an exposed internal wire.There were no fragments found and no thermal damage were observed.The instrument passed electrical continuity test.Upon further evaluation, the fenestrated bipolar forceps instrument was found to have scratch marks/abrasions on the edge of the bipolar yaw pulley.The scratch marks/abrasions were found on both side of the bipolar yaw pulley.Additionally, indentations/burrs on the edge of the distal idler pulleys were found.The fenestrated bipolar forceps instrument was found to have a frayed grip cable at the distal idler pulley.The frayed cable strands stuck out at the wrist.The instrument was found to have various scratch marks with light material removed on the main tube.The scratch marks were 0.052¿ - 0.399 in length and were not aligned with the tube axis.

Manufacturer Narrative

Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use with no damage observed.The thermal damage was identified after the procedure when the nurse was cleaning the instrument.The surgeon believes the issue was caused by product quality.There was instrument collision with an unspecified energy instrument during the procedure.There was no arcing observed and no injury to the patient.

• 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: 18664812
• MDR Text Key: 334832397
• Report Number: 2955842-2024-11141
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470205-17
• Device Catalogue Number: 470205
• Device Lot Number: K10230323 0095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2023
• 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