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

Model Number 470361

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 12/20/2019

Event Type  malfunction  

Event Description

Opening trocar cap on the back table during setup and noticed a curled gray object.The items, cap seal and object were removed from the sterile field and table covered with sterile drape.Patient was not in the room.It looks like a gray plastic particle from the cap.

• Brand Name: None
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 9480618
• MDR Text Key: 171598595
• Report Number: 9480618
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00886874112540
• UDI-Public: (01)00886874112540(17)210930(10)L11190924
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470361
• Device Lot Number: L11190924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9490 DA
• Patient Weight: 94