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

Model Number 471172-16

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the 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 yaw pulley showed signs of charring and localized melting at the base of the grip on their exterior.The thermal damage to the yaw pulley is unrelated to the conductor wire on this instrument.No insulation damage was observed.The conductor wire is not damaged or broken.An electrical continuity test was performed and passed.The root cause for this failure is attributed to user mishandling misuse, commonly caused by 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 maryland bipolar forceps (part# 471172-16 / lot# n11200622/ sequence# (b)(4)) associated with this event has been performed.Per this review of the logs, the instrument was last used on (b)(6) 2022 on system serial# (b)(4) with 2 uses remaining.Based on this review, the instrument was not used in the reported event date or in any subsequent procedure(s) after its last used.There was no image or video clip submitted for review.Field implant date is blank because the product is not implantable.

Event Description

It was reported that prior to the start of a da vinci-assisted surgical procedure, the maryland bipolar forceps had burnt rubber at the tip.The procedure was completed with no reported injury.There was no patient involvement.

• 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: 14257864
• MDR Text Key: 290476306
• Report Number: 2955842-2022-11368
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119792
• UDI-Public: (01)00886874119792(10)N11200622
• 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: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471172-16
• Device Catalogue Number: 471172
• Device Lot Number: N11200622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2020
• 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 Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES