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

Model Number 471093-11

Device Problem Break (1069)

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

Event Date 01/20/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted surgical procedure, the 8mm prograsp forceps instrument was stuck and damaged.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) 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

Intuitive surgical, inc.(isi) received the 8mm prograsp forceps instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) replicated/confirmed the customer reported complaint.The prograsp forceps instrument was found to have a broken main tube and a piece measuring approximately 0.083¿ x 0.237¿ was not returned with the instrument.The root cause of the broken main tube is typically attributed to mishandling/ misuse.An additional observation not reported by the customer was also identified.The prograsp forceps instrument was found to have various scratch marks with light material removed on the main tube.The scratch marks were 0.072¿ - 0.165 in length and were not aligned with the tube axis.The root cause of the scratch marks /abrasions on the instrument main tube is typically attributed to mishandling/misuse.A review of the instrument log for the prograsp forceps (471093-11/k102107050077) associated with this event has been performed.Per logs, the prograsp forceps instrument was last used on (b)(6) 2022 on system (b)(4).The instrument had 12 uses remaining after the last procedural use.An event verification confirmed the procedure was performed on the reported event date.A review of the site's complaint history does not show any additional complaints related to this product.No image or video of the last procedure was provided for review.This complaint is being reported due to the following conclusion: failure analysis acknowledged 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 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: 14132398
• MDR Text Key: 298867531
• Report Number: 2955842-2022-11118
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119785
• UDI-Public: (01)00886874119785(10)K10210705
• 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
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2022
• 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: K10210705 0077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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 Ethnicity: Non Hispanic
• Patient Race: Asian