MAUDE Adverse Event Report: INTUITIVE SURGICAL INC DA VINCI SI PERMANENT CAUTERY HOOK; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number 420183

Device Problems Break (1069); Device Slipped (1584)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Da vinci si permanent cautery hook tip broken.Black tip cover/piece loose and not secure.Determined not safe for patient use.

• Brand Name: DA VINCI SI PERMANENT CAUTERY HOOK
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): INTUITIVE SURGICAL INC; sunnyvale CA 94086
• MDR Report Key: 8023588
• MDR Text Key: 125934784
• Report Number: MW5080941
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/29/2018

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 Model Number: 420183
• Device Catalogue Number: 420183
• Device Lot Number: N10180712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2018
• 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