MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; SMALL GRASPING RETRACTOR

Model Number 470318-10

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the small grasping retractor associated with this complaint and completed investigations.Failure analysis investigations confirmed the customer reported complaint of a broken/loose cable.Failure analysis found the primary failure of broken/loose cable to be related to the customer reported complaint.The instrument was found to have a broken pitch cable at the distal end.The broken cable segment that contains the crimp was still installed in the clevis.Root cause of this failure is attributed to a component failure.Additional observation not reported by site: the instrument was found to have various scratch marks with light material removed on the main tube.The scratch marks were 0.041¿ - 0.257" in length and were not aligned with the tube axis.This failure is most commonly caused by mishandling/misuse.Root cause of this failure is attributed to mishandling.A review of the instrument log for the small grasping retractor (part # 470318 / lot # n10191104 0109) associated with this event has been performed.Per logs, the small grasping retractor was last used on (b)(6) 2020 on system (b)(4), with 4 uses remaining.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.Based on the information provided at this time, this complaint is being reported because this instrument is designed with two pitch cables, each with a crimp at the distal end.If a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall into the patient.While there was no harm or injury to patient, the failure mode identified in failure analysis of the product could cause or contribute to an adverse event if it were to recur.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the wire was broken.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST
• Type of Device: SMALL GRASPING RETRACTOR
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 11217671
• MDR Text Key: 238922113
• Report Number: 2955842-2021-10080
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112441
• UDI-Public: (01)00886874112441(10)N10191104
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470318-10
• Device Catalogue Number: 470318
• Device Lot Number: N10191104 0109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Date Manufacturer Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2019
• 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