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

Model Number 470172-17

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 12/21/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation is in progress to determine the cause of this reported event.An return material authorization (rma) was issued to evaluate the intuitive surgical, inc.(isi) device.Additional information is being gathered to determine the contribution of the device to the customer reported issue.

Event Description

It was reported that after a da vinci-assisted pulmonary lobectomy surgical procedure, the maryland bipolar forceps instrument had a melted insulation layer.The procedure was completed with no reports of patient injury.

Manufacturer Narrative

Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the maryland bipolar forceps instrument was inspected prior to use with no damage observed.The issue was identified during procedure while cleaning the instrument.There was instrument collision with an unspecified energy instrument during procedure.There was no arcing observed.There was no patient injury.

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The maryland bipolar forceps instrument was analyzed and found to have no melted insulation layer and no thermal damage observed.The instrument failed the electrical continuity issue and there was no obvious damage to the conductor wire.The housing was removed for inspection and the conductor wire was found to be dislodged from the connector at the proximal end.The conductor wire was re-installed, and the instrument performed properly.The instrument also had scratch marks/abrasions on the edge of the bipolar yaw pulley.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.

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: 18660758
• MDR Text Key: 334779991
• Report Number: 2955842-2024-11135
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131861
• 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,Followup
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470172-17
• Device Catalogue Number: 470172
• Device Lot Number: K10230427 0505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 01/15/2024; 03/04/2024
• Supplement Dates FDA Received: 03/02/2024; 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2023
• 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