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

Model Number 471049

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2022

Event Type  malfunction  

Event Description

One of the turning knobs where the robot instrument connects to the drape broke off.

• Brand Name: CADIERE FORCEPS
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 14336454
• Report Number: 14336454
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 471049
• Device Catalogue Number: 471049
• Device Lot Number: K10211206 0021
• 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: 04/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown
• Patient Age: 20805 DA
• Patient Sex: Female
• Patient Weight: 105 KG
• Patient Outcome(s): Other