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

Model Number 471172-17

Device Problems Thermal Decomposition of Device (1071); Material Split, Cut or Torn (4008)

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

Event Date 12/07/2023

Event Type  malfunction  

Event Description

It was reported that after a da vinci-assisted sacrocolpopexy surgical procedure, the conductor wire insulation of the maryland bipolar forceps (mbf) had a thermal damage.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use with no issue.Thermal damage and conductor wire insulation damage were observed after the procedure.The surgeon did not notice any damage during the procedure.The procedure was completed with no patient injury.

Manufacturer Narrative

Intuitive has received the part associated with this complaint and completed investigations.Failure analysis investigations replicated a confirmed the customer reported complaint.The instrument was found to have charring and localized melting on the bipolar yaw pulley.The thermal damage was found at the base of the yaw pulley near the grip.As a result, the electrode was exposed.The instrument grips were manually manipulated, and the instrument passed electrical continuity test on 3 out of 3 attempts.The instrument was placed and driven on an in-house system.The instrument delivered energy with no signs of arcing on 3 of 3 attempts.

Manufacturer Narrative

Failure analysis confirmed no conductor wire damage.

Event Description

Refer to h10/h11 for follow-up information.

• 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: 18509425
• MDR Text Key: 332867688
• Report Number: 2955842-2024-10118
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(10)K11230302
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2024
• 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: K11230302 0482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2024
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2023
• 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