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 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The maryland bipolar forceps instrument was analyzed.Visual inspection found no damage to the instrument's cable.No product issue was identified.The complaint was not confirmed by failure analysis.Additionally, the instrument was found to have charring and localized melting near the grip base on the outside of the yaw pulley.The instrument was placed and driven on an in-house system.The instrument passed the electrical continuity test.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.The instrument delivered energy on several attempts.No arcing was observed.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the maryland bipolar forceps had a broken wire at the wrist.The procedure was completed with no reported injury.

• 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: 18592493
• MDR Text Key: 333893654
• Report Number: 2955842-2024-10722
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(10)K11220711
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/12/2024

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: K11220711 0073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2023
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2022
• 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