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

Model Number 420172-17

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 03/08/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received (b)(4) involved with this complaint and completed the device evaluation.Failure analysis investigation revealed that the instrument was installed onto a test system and passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.No recognition or engagement error codes were found in logs.Additionally, the instrument was tested multiple times and passed with no issues.Additional observation not reported was the instrument was found to have thermal damage on the bipolar yaw pulley.The instrument passed the electrical continuity.The root cause of this failure is attributed to mishandling/misuse.A review of the site's complaint history identified no other complaints related to the instrument and/or this event.No image or procedure video was provided for review.Verification of the instrument logs cannot be performed because the system was not online at the time.Based on the failure analysis, this complaint is being classified as a reportable event due to the following conclusion: the instrument had thermal damage on the bipolar yaw pulley.The instrument passed the electrical continuity.The root cause of this failure is attributed to mishandling/misuse.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Follow-up was attempted, but patient information in sections was either unknown, unavailable, not provided, or not applicable.The expiration date for section is not applicable.Field is blank because the product is not implantable.Information for the blank fields in initial reporter is not available.Fields are not applicable.

Event Description

It was reported that prior to a da vinci-assisted surgical procedure, (b)(4) was not recognized.A backup instrument of the same type was used and the procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made follow up attempt to obtain additional information.However, no further details have been received as of the date of this report.

• Brand Name: ENDOWRIST;DAVINCI SI
• 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: 14299195
• MDR Text Key: 290904081
• Report Number: 2955842-2022-11419
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111475
• UDI-Public: (01)00886874111475(10)N10210215
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420172-17
• Device Catalogue Number: 420172
• Device Lot Number: N10210215 0468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2021
• 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