MAUDE Adverse Event Report: INTUITIVE SURGICAL UNIT DAVINCI SI VESSEL SEALER; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number SI

Device Problem Stretched (1601)

Patient Problem No Information (3190)

Event Date 04/24/2019

Event Type  malfunction  

Event Description

Da vinci si vessel sealer, first instrument staff identified "stretched" energy cable at the distal end of instrument.Removed from sterile field and replaced.

• Brand Name: DAVINCI SI VESSEL SEALER
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL UNIT; 950 kifer road; sunnyvale CA 94086
• MDR Report Key: 8600333
• MDR Text Key: 144873389
• Report Number: MW5086534
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2019

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: SI
• Device Catalogue Number: 410322-05
• Device Lot Number: M11181014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2019
• 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