MAUDE Adverse Event Report: INTUTIVE SURGICAL DA VINCI S; ROBOTIC HANDPIECE, PERMINENT CAUTERY HOOK

Catalog Number 420183

Device Problems Material Separation (1562); Malposition of Device (2616)

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

Event Date 09/20/2019

Event Type  malfunction  

Event Description

During procedure using robotic permanent cautery hook, the handpiece experienced failure in the cautery hook holding trunnions on the hand piece.The trunnions separated from the handpiece which caused the cautery hook to not position correctly for cautery.The handpiece was retracted and disconnected from the robotic surgical system.Case proceeded without incident.

• Brand Name: DA VINCI S
• Type of Device: ROBOTIC HANDPIECE, PERMINENT CAUTERY HOOK
• Manufacturer (Section D): INTUTIVE SURGICAL; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 9161200
• MDR Text Key: 161373741
• Report Number: 9161200
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 420183
• Device Lot Number: N10181025142
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16425 DA