MAUDE Adverse Event Report: INTUITIVE SURGICAL ENDO WRIST ONE VESSEL SEALER; ENDO WRIST VESSEL SEALER

Model Number 410322

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2016

Event Type  malfunction  

Event Description

During a laparoscopic hysterectomy, the da vinci robot was docked in the normal fashion.Instruments were inserted and the surgery was performed using the robotic console.The left utero-ovarian ligament was then grasped with the vessel sealer.The vessel sealer jaws locked after initial placement.Device replaced.No pt harm.Diagnosis or reason for use: uterine blooding.Is the product compounded? no.Is the product over-the-counter? no.

• Brand Name: ENDO WRIST ONE VESSEL SEALER
• Type of Device: ENDO WRIST VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 5938941
• MDR Text Key: 54432902
• Report Number: MW5064614
• Device Sequence Number: 1
• Product Code: NAY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/22/2016

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 Expiration Date: 07/01/2017
• Device Model Number: 410322
• Device Lot Number: M10150722
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2016
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 61