MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. CAUTERY SPATULA; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Insufficient Information (4580)

Event Date 04/19/2021

Event Type  malfunction  

Event Description

Da vinci cautery spatula inserted into port site of patient.Md noticed wires sticking out by the tip of the cautery spatula.Da vinci instrument removed from patient and from sterile field.Service coordinator made aware.

• Brand Name: CAUTERY SPATULA
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 12165606
• MDR Text Key: 261473491
• Report Number: 12165606
• 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: 07/09/2021,04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA
• Patient Weight: 125