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 12/19/2023

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the da vinci product with an alleged issue to perform failure analysis.A follow-up mdr will be submitted if the product is returned and evaluated and/or if additional information is received.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the maryland bipolar forceps was observed to have thermal damage to the pulley cover.The procedure was completing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up and obtained the following additional information: the maryland bipolar forceps was inspected prior to use and there was no damage or anything out of the ordinary that was noted.The thermal damage was first observed intraoperatively during use of the maryland bipolar forceps, and the surgeon believes that the forceps burned.The maryland bipolar forceps did not collide with an energy instrument during the procedure.The customer was unable to say if arcing did or did not occur.There was no patient injury or harm.There was no surgical delay.

Manufacturer Narrative

An intuitive surgical, inc.(isi) did receive the maryland bipolar forceps instrument to perform failure analysis.The instrument was found to have thermal damage between the grip of the instrument bipolar yaw pulley.The maryland bipolar forceps was found to have charring and localized melting at the grip base between the grips.The instrument passed the electrical continuity test.The complaint was confirmed by failure analysis.

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: 18545702
• MDR Text Key: 333274223
• Report Number: 2955842-2024-10460
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(11)230608(10)K12230608(91)0009
• 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: 12/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• 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 0215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/06/2024
• 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.