MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. NONE; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number 371939

Device Problem Device Fell (4014)

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

Event Date 12/27/2019

Event Type  malfunction  

Event Description

During surgical procedure, surgeon was unable to see through scope.The scope was removed and the lens fell off.

• Brand Name: NONE
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 950 kifer rd; sunnyvale CA 94086
• MDR Report Key: 9636240
• MDR Text Key: 176585042
• Report Number: 9636240
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/10/2020,01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 371939
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2020
• Date Report to Manufacturer: 01/28/2020
• Type of Device Usage: N
• Patient Sequence Number: 1