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

Model Number 471205-17

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Insufficient Information (4580)

Event Date 03/14/2022

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 (fa) confirmed the reported complaint of "burnt rubber at the tip. " the instrument was found to have thermal damage on the bipolar yaw pulley. The known common cause of this failure is due to instrument mishandling and misuse such as collision with another energized instrument. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. A review of the instrument log for the fenestrated bipolar forceps (part# 471205-17 / lot# k10210907 / sequence# 0133) associated with this event has been performed. Per this review of the logs, the instrument was last used for a procedure on (b)(6) 2022 on system serial# (b)(4). Based on this review, the instrument was not used in the reported event date or in any subsequent procedure(s) after its last usage. There was no image or video clip submitted for review. Based on the additional information obtained from failure analysis investigations, this complaint is being reported as a reportable event due to the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage. Failure analysis confirmed thermal damage on the bipolar yaw pulley. 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 that prior to the start of a da vinci-assisted surgical procedure, routine inspection of the fenestrated bipolar forceps instrument identified burnt rubber at the tip. No patient involvement.

• Brand Name: ENDOWRIST
• 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: 14108485
• MDR Text Key: 289246031
• Report Number: 2955842-2022-11029
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 471205-17
• Device Catalogue Number: 471205
• Device Lot Number: K10210907 0133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2021
• 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 Treatment Data

Date Received: 04/13/2022 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES