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

Model Number 471049-07

Device Problems Break (1069); Scratched Material (3020)

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

Event Date 01/19/2022

Event Type  malfunction  

Event Description

It was reported that the cadiere forceps instrument had a broken or loose cable.There were no reports of patient 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

Intuitive surgical, inc.(isi) received the cadiere forceps instrument involved with this complaint and completed the device evaluation.The failure analysis (fa) investigation did not replicate nor confirm the customer's reported complaint of a broken or loose cable.The instrument was found to have a broken grip at the grip base.A piece approximately 0.21" x 0.64" was found to be broken off of the yaw pulley.The broken piece was not returned.The root cause of broken instrument grips -tips is typically attribute to mishandling/misuse, such as excess force applied to the instrument jaws.The instrument was found to have various scratch marks, with light material removed, on the main tube.The scratch marks were 0.096¿ - 0.161" in length and were not aligned with the tube axis.The root cause of scratch marks /abrasions on instrument 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 procedure video was provided for review.A log review was performed for the cadiere forceps instrument reported in this complaint (part #: 471049-07/n11200817 0240).Per the logs, instrument was last used on 19-jan-2022.The instrument had 1 use remaining and was not used for any subsequent procedures.This complaint is being reported due to the following conclusion: the instrument had scratches, with light material removed, on the main tube.Failure analysis also acknowledged 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 a 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: CADIERE 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: 13699141
• MDR Text Key: 296859554
• Report Number: 2955842-2022-10539
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119778
• UDI-Public: (01)00886874119778(10)N11200817
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471049-07
• Device Catalogue Number: 471049
• Device Lot Number: N11200817 0240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2020
• 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