MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. TIP COVER ACCESSORY

Catalog Number 400180

Device Problem Detachment Of Device Component (1104)

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

Event Date 12/06/2017

Event Type  malfunction  

Event Description

Surgeon was performing a robotic myomectomy and the scissor tip cover came off of the robotic scissors inside the pt.The tip cover was retrieved and no harm was noted.Surgeon manually looked for the scissor tip cover until found, as it is not radiopaque so could not use x-ray to locate.Was under anesthesia longer than anticipated due to the event.

• Brand Name: TIP COVER ACCESSORY
• Type of Device: TIP COVER ACCESSORY
• Manufacturer (Section D): INTUITIVE SURGICAL INC.; sunnyvale CA 94086
• MDR Report Key: 7124307
• MDR Text Key: 95186010
• Report Number: MW5074057
• Device Sequence Number: 1
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 400180
• Device Lot Number: M10170906
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2017
• 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: 40 YR
• Patient Weight: 83