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

Model Number 420183

Device Problem Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2017

Event Type  malfunction  

Event Description

Da vinci monopolar hook sparked (joint arched) in patient.It did not cause patient harm but the instrument was removed and sent to intuitive for evaluation manufacturer response for permanent cautery hook, da vinci s (per site reporter): rep came and picked up defective product for evaluation.

• Brand Name: PERMANENT CAUTERY HOOK
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 950 kifer rd; sunnyvale CA 94086
• MDR Report Key: 6746502
• MDR Text Key: 81141933
• Report Number: 6746502
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 420183
• Device Catalogue Number: 420183
• Device Lot Number: N11160719 729
• Other Device ID Number: 8MM PERMANENT CAUTERY HOOK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Weight: 82