MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. DA VINCI; PERMANENT CAUTERY HOOK (XI)

Model Number XI

Device Problem Component Missing (2306)

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

Event Date 11/15/2017

Event Type  malfunction  

Event Description

This intuitive (xi) instrument - permanent cautery hook was last used on (b)(6) 2017 with 7 lives remaining at the conclusion of the case.A grey disc on the housing cassette is missing.The instrument was returned with no indication as to whether this occurred during the case or after the processing in spd (after the case).

• Brand Name: DA VINCI
• Type of Device: PERMANENT CAUTERY HOOK (XI)
• Manufacturer (Section D): INTUITIVE SURGICAL INC.; sunnyvale CA 94086
• MDR Report Key: 7471923
• MDR Text Key: 107069071
• Report Number: MW5076831
• Device Sequence Number: 0
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XI
• Device Catalogue Number: 470183 VER11
• Device Lot Number: N10170602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 73