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

Model Number 471093-11

Device Problem Entrapment of Device (1212)

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

Event Date 06/18/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted radical with lymphadenectomy prostatectomy surgical procedure, the prograsp forceps instrument was not working (the instrument jaws were not opening completely).The procedure was completed with no reported injury.The prograsp forceps is a multiple-use endoscopic instrument with a grasping tip to be used in conjunction with the da vinci system.The instrument is designed to grab, manipulate, retract, and dissect tissue during a da vinci assisted surgical procedure.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the prograsp forceps instrument was not working (jaws were not opening completely).The instrument jaws were stuck on the tissues and removed slowly by the surgeon.The instrument release kit (irk) was not used.There was no patient injury.The prograsp forceps instrument was inspected prior to use and no damage was noted.The issue was resolved by using the back up instrument.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has requested that the prograsp forceps instrument be returned for evaluation, but it has not yet been returned.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.A review of the instrument logs for the prograsp forceps (part number 471093-11/ lot number k10220104 0216) associated with this event has been performed.Per the review, the prograsp forceps instrument was last used in a procedure on 18-june-2022 on system sk5098.The alleged instrument had 10 uses remaining after the last procedural use.Isi received a video clip related to the alleged complaint.A review of the image was conducted by an isi clinical development engineer (cde) and found the following information: there is some tissue in the jaws of the prograsp, and at no time in the video is the instrument stuck to tissue.This complaint is considered a reportable malfunction event due to the following conclusion: it was alleged that the tissue was stuck in the prograsp forceps instrument's jaws when the instrument failed to release from tissue.Medical intervention may be required in the event that the instrument fails to release from tissue when commanded by the user or system.At this time, it is unknown what caused the unclamping event 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.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the prograsp forceps instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigations did not replicate nor confirm the customer reported complaint.Fa found the primary failure of could not reproduce - could not verify external event to be related to the customer reported complaint.Visual inspection found no damage to the grips or blades.The prograsp forceps instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.The prograsp forceps instrument passed the grip bumper test.The instrument was fully functional.The prograsp forceps instrument was tested multiple times and there was no problem detected.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• 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: 15047011
• MDR Text Key: 304717543
• Report Number: 2955842-2022-13032
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119785
• UDI-Public: (01)00886874119785(10)K10220104
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471093-11
• Device Catalogue Number: 471093
• Device Lot Number: K10220104 0216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2021
• 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
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian