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

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 08/23/2021

Event Type  malfunction  

Event Description

Product would not rotate, went side to side, lacked full range of motion.

• 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: 12369829
• MDR Text Key: 268231812
• Report Number: 12369829
• 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: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1