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

Model Number 471093-11

Device Problems Break (1069); Fracture (1260)

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

Event Date 01/04/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the prograsp forceps was not working properly. 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) completed customer follow-up and obtained the following information: the customer confirmed the instrument was not working properly and there was no report of any fragments falling into the patient. The site completed the procedure and there was no patient injury nor has the patient returned to the hospital due to post-surgery complications.

Manufacturer Narrative

Intuitive surgical, inc. (isi) received the prograsp forceps instrument involved with this complaint and completed the device evaluation. Failure analysis (fa) did not replicate nor confirm the reported issue as the instrument passed in house testing and the instrument fully functioned without issue. However, fa found the main tube broken from the instrument. A piece measuring approximately 0. 32¿ x 0. 103¿ was not returned. Fa attributed the root cause of the broken main tube to the user. 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 device logs for the prograsp forceps (part# 471093-11 | lot-sequence# k10210607 0079) has been performed. Per this review of the logs, the prograsp forceps was last used on 19-nov-2021 on system sk4200. The alleged event occurred on the 14th use of the instrument. The instrument has 18 total uses. No image or video of the procedure was provided for review. This complaint is considered a reportable event due to the following conclusion: failure analysis acknowledges that a fragment was missing from a portion of the device that enters the patient. Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure. While there was no report of harm or injury to the patient and no report of fragments falling into the patient, the reported failure mode could likely cause or contribute to an adverse event if the fragment(s) did fall into the patient.

• 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: 13657118
• MDR Text Key: 296701035
• Report Number: 2955842-2022-10442
• 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

• Type of Report: Initial
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 471093-11
• Device Catalogue Number: 471093
• Device Lot Number: K10210607 0079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2021
• 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: 03/02/2022 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES