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

Model Number 470172-16

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 11/14/2023

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the maryland bipolar forceps (mbf) instrument failed to deliver energy.The customer used a backup instrument to continue with the procedure.No fragment fell inside the patient.No known impact or patient consequence was reported.

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive the maryland bipolar forceps (mbf) instrument to perform failure analysis.The reported complaint was not confirmed by failure analysis.The instrument was placed and driven on an in-house system.The maryland bipolar forceps (mbf) instrument passed the recognition, engagement, electrical continuity and energy delivery tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.The instrument was further inspected and found charring and localized melting at the grip base between the grips and on the outer surface of one bipolar yaw pulley, resulting in an exposed electrode.Thermal damage is attributed to carbonized tissue on the grips of this bipolar instrument creating a conductive path during use.Thermal damage can also result due to inadvertent energy application from a monopolar instrument.

• 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: 18540272
• MDR Text Key: 333193527
• Report Number: 2955842-2024-10329
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112281
• UDI-Public: (01)00886874112281(10)N13191028
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131861
• 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: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470172-16
• Device Catalogue Number: 470172
• Device Lot Number: N13191028 0019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2019
• 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
• Patient Sex: Female