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

Model Number 471172-17

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 10/21/2023

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted donor hepatectomy surgical procedure, the maryland bipolar forceps instrument was not properly articulating.The user completed the procedure using the backup instrument with no further issue reported.No fragment fell inside the patient.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the clinical sales representative (csr) and obtained the following additional information: there was no arcing observed during the procedure.The instrument did not collide with any other instrument or tool during the procedure.There was no problem in removing the instrument through the cannula.There was no loss of cautery associated with the damaged cable.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the maryland bipolar forceps instrument for failure analysis.The maryland bipolar forceps instrument was analyzed and found to have a broken, loose and frayed grip cable at the distal end.The frayed cable strands stuck out at the wrist.Further inspection identified a frayed pitch cable at the distal end.These failure analysis findings confirmed the reported issue.Additional finding not related to customer reported complaint: the instrument was found with charring and/or localized melting on the outer surface of one bipolar yaw pulley.The instrument passed the electrical continuity test.

• Brand Name: ENDOWRIST
• Type of Device: MARYLAND 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: 18588185
• MDR Text Key: 333851420
• Report Number: 2955842-2024-10721
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(11)230515(10)K13230515(91)0007
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471172-17
• Device Catalogue Number: 471172
• Device Lot Number: K13230515 0021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2023
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2023
• 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