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

Model Number 420205-16

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc. (isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation. Failure analysis confirmed the reported complaint. The instrument was found to have charring and localized melting at the grip base between the grips. This failure is most commonly caused by insulation degradation and carbonized tissue creating a conductive path. The fenestrated bipolar forceps instrument passed the electrical continuity test. The root cause of the thermal damage between the grips is attributed to use. It was noted the instrument had 6 lives remaining. The instrument logs show that the customer last used the fenestrated bipolar forceps instrument (part # 420205-15, lot # n12200803-0827) on (b)(6) 2020 during a total benign hysterectomy procedure on system serial# (b)(4). The instrument had 6 lives remaining. A review of the site's system logs for the reported procedure date was performed and no related system errors were noted to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint. This complaint is being reported due to the following conclusion: it was reported the fenestrated bipolar forceps instrument had burnt plastic at the distal end. At this time, it is unknown what caused the thermal damage to occur. 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.

Event Description

It was reported the fenestrated bipolar forceps instrument had burnt plastic on the end. No further details, including when the issue was identified, were provided. There was no reported injury or harm. Intuitive surgical, inc. (isi) followed up with the initial reporter and obtained the following additional information: the initial reporter informed isi that the instrument had been dropped off on her desk with limited information, and no additional information could be provided. Isi made multiple additional follow-up attempts to obtain additional information. No further details have been received as of the date of this report.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: FENESTRATED 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: 14325477
• MDR Text Key: 291191220
• Report Number: 2955842-2022-11471
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 420205-16
• Device Catalogue Number: 420205
• Device Lot Number: N12200803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2020
• 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 Treatment Data

Date Received: 05/07/2022 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES