MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. TIP COVER ACCESSORY; SYSTEM, SURGICAL, COMPUTER

Model Number 400180

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2018

Event Type  malfunction  

Event Description

At the end of case the protective sheath was noted to have a hole in the cover.There was no harm to the patient.

• Brand Name: TIP COVER ACCESSORY
• Type of Device: SYSTEM, SURGICAL, COMPUTER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer rd; sunnyvale CA 94086
• MDR Report Key: 7955503
• MDR Text Key: 123371947
• Report Number: 7955503
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 400180
• Device Catalogue Number: 400180
• Device Lot Number: M10180612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/04/2018
• Date Report to Manufacturer: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21170 DA