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 01/16/2024

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted surgical procedure, the maryland bipolar forceps (mbf) instrument pulley cover had a thermal damage.The customer used a backup mbf instrument to continue with the planned procedure.No fragment fell inside the patient.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information: the mbf instrument was inspected prior to use with no issue.The customer observed charred tissue on the instrument.There was no report of the tissue being burned unexpectedly.The instrument did not collide with any energy instrument during the procedure.There was no arcing observed during the procedure.There was no patient injury.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the maryland bipolar forceps instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the maryland bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed the reported complaint.The instrument was found to have charring and localized melting at the grip base between the grips.The instrument passed the electrical continuity test.The instrument was placed on an in-house system, and no arcing was observed.

• 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: 18691798
• MDR Text Key: 335184129
• Report Number: 2955842-2024-11249
• Device Sequence Number: 1
• Product Code: NAY
• 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: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• 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: K12230608 0058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2023
• 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