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

Model Number 471172-17

Device Problems Thermal Decomposition of Device (1071); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 10/10/2023

Event Type  malfunction  

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 thermal damage on the bipolar yaw pulley.Additionally, the instrument was found to have the conductor wire insulation damaged.There was material missing.Material missing measures approximately 029" x.085".As a result, the conductor wires were exposed.The instrument passed an electrical continuity test.

Event Description

It was reported that after a da vinci-assisted simple prostatectomy surgical procedure, a fault at the tip was found when the maryland bipolar forceps instrument was inspected.The tip appeared to be grooved or cracked.The procedure was completed.No known impact or patient consequence was reported.

Manufacturer Narrative

Intuitive surgical inc.(isi) followed up with the initial reporter and obtained the following additional information: it is not possible to say that the missing material/damage was outside the procedure.However, the damage was only identified in the cme during the washing process.There were no reports of fragments falling from the device while used within the patient.All patients undergoing robotic surgery are monitored by the hospital's sccih.If there are fragments, the surgeon in charge will deal with them.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retention of foreign material.Thermal damage was not observed.The damaged was verified after the event in the cme sector, and it is not possible to verify if arcing was observed during the procedure.

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: 18508988
• MDR Text Key: 332867895
• Report Number: 2955842-2024-10282
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(10)K10220614
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• 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: K10220614 0111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2022
• 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.
• Patient Sex: Male