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 12/23/2021

Event Type  malfunction  

Manufacturer Narrative

The prograsp forceps instrument has been returned and was evaluated by the failure analysis team.Failure analysis investigations confirmed the reported complaint "tip of the shaft breaks." failure analysis found the primary finding of main tube broken to be related to the customer reported complaint.The instrument was found to have the main tube broken towards the distal end causing the proximal clevis to be dislodged.A piece measuring approximately 0.229¿ x 0.660¿ was not returned with the instrument.The root cause of broken instrument's main tube is typically attributed to mishandling/misuse.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or video was provided for review.A review of the instrument log for the prograsp forceps instrument (part# 71093-11/k11210726 0264) associated with this event has been performed.Per logs, the prograsp forceps instrument was last used on (b)(6) 2021 on system (b)(4).The instrument had 11 remaining usable lives with no subsequent use recorded.This complaint is being reported based on the following conclusion: failure analysis acknowledges that a fragment was missing from a portion of the device that enters the patient (distal end).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, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.

Event Description

It was reported that after a da vinci-assisted hysterectomy (malignant) surgical procedure, the tip of the shaft on the prograsp forceps instrument broke and the arm instrument was released together with the 8mm port.The procedure was completed with no reported injury.On 03/21/2022, additional information was received from the customer: the shaft of the prograsp forceps instrument broke after the procedure, while the console surgeon was about to remove the instrument.The instrument was fully intact and was removed from the body together with the 8mm ports.No fragment fell inside the abdomen and there was no further issue that occurred.The hospital declined to provide patient 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: 14060061
• MDR Text Key: 298499645
• Report Number: 2955842-2022-10955
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119785
• UDI-Public: (01)00886874119785(10)K11210726
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: K11210726 0264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2021
• 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: Female