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

Model Number 420093-14

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

The prograsp forceps instrument was requested to be returned, but it has not yet been received by isi for evaluation.Therefore the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.Review of the provided image is consistent with the grip pin loose / dislodged at the distal end.Root cause of the failure mode cannot be confirmed without the returned device.A review of the instrument log for the prograsp forceps instrument (pn# 420093-14 lot# n10201207-592) associated with this event has been performed.Per logs, the instrument was used on the reported event date of (b)(6) 2021 on system sh2338 for approximately 10 minutes.The alleged event occurred on the 1st use of the instrument.A review of the site's complaint history does not reveal any related or duplicate complaints involving this product and/or this event.This complaint is being reported due to the following conclusion: the instrument's pin was loose with no evidence or claim of user 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.

Event Description

It was reported that during a da vinci-assisted partial nephrectomy surgical procedure, the screw that holds the handle to the jaw of the prograsp forceps instrument had loosened.A backup instrument of the same type was used and the procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

Manufacturer Narrative

Additional information can be found in the following fields: d9, g3, g6, h2, h3, h6, and h10.D03 - intuitive surgical, inc.(isi) received the prograsp forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint.Visual inspection was performed and the grip pin was found to be dislodged.When compared to a test instrument, the instrument was found to have improper swaging of the grip pin.This failure likely caused the grip pin to be dislodged.No material appeared to be missing.The instrument was placed and driven on 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.Root cause of this failure is attributed to manufacturing.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: PROGRASP 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: 13085600
• MDR Text Key: 286745126
• Report Number: 2955842-2021-11811
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111345
• UDI-Public: (01)00886874111345(10)N10201207
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420093-14
• Device Catalogue Number: 420093
• Device Lot Number: N10201207 592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2020
• 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