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 12/05/2023

Event Type  malfunction  

Manufacturer Narrative

A return material authorization (rma) was issued to evaluate the maryland bipolar forceps instrument.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.

Event Description

It was reported that during a da vinci-assisted radical prostatectomy without lymphadenectomy surgical procedure, the maryland bipolar forceps instrument had a melted wrist.The user completed the procedure 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 initial reporter and obtained the following additional information: the instrument was inspected prior to use with no damage observed.The thermal damage was first identified during the use of the instrument.The surgeon was unsure what caused the thermal damage.There was no instrument collision and no arcing observed.There was no injury to the patient.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the maryland bipolar forceps instrument to perform failure analysis.The maryland bipolar forceps instrument was analyzed and 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.The electrode was exposed as a result.The instrument passed an electrical continuity test.The instrument was placed and driven on an in-house system and delivered energy with no signs of arcing.

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: 18699304
• MDR Text Key: 335278396
• Report Number: 2955842-2024-11140
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K214095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• 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: K10230615 0212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2023
• 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
• Patient Sex: Male