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

Model Number 470318-08

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 01/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Surgical, inc (isi) received the instrument involved with the complaint and completed the device evaluation.Failure analysis confirmed the customer reported failure mode.The instrument was found to have a broken pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was missing from clevis.The clevis did not exhibit any damage or wear marks.Other cables at the wrist were not damaged.A device history record (dhr) review for the device involved with the complaint has been completed.No non-conformancies were identified to be related to this complaint.The customer reported complaint does not itself constitute an mdr reportable event; however, the broken pitch cable found during failure analysis could cause or contribute to an adverse event if the failure mode were to recur.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the small grasping retractor instrument had a "wire exposed".There was no report of fragments falling inside the patient.The planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported.

• Brand Name: ENDOWRIST
• Type of Device: SMALL GRASPING RETRACTOR
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer Contact: tabitha reed ; 950 kifer rd.; sunnyvale ; 4085232100
• MDR Report Key: 7330333
• MDR Text Key: 102097914
• Report Number: 2955842-2018-10053
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470318-08
• Device Lot Number: N10170918 0117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES