MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Catalog Number 471172

Device Problems Break (1069); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 08/26/2021

Event Type  malfunction  

Event Description

Upon starting to use the maryland bipolar davinci instrument, it was noticed that it was not working properly due to a loose or broken wire.

• Brand Name: ENDOWRIST
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 12614696
• Report Number: 12614696
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 471172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown
• Patient Age: 25185 DA
• Patient Weight: 75