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

Model Number DAVINCI XI

Device Problems Break (1069); Material Frayed (1262)

Patient Problem Insufficient Information (4580)

Event Date 03/21/2022

Event Type  malfunction  

Event Description

Upon inspection, instrument found to have broken or frayed cables.Fda safety report id # (b)(4).

• Brand Name: DAVINCI PROGRASPS FORCEPS
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL INC.; sunnyvale CA 94086
• MDR Report Key: 15043317
• MDR Text Key: 296140455
• Report Number: MW5110913
• 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: Unknown
• Type of Report: Initial
• Report Date: 07/13/2022

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: DAVINCI XI
• Device Catalogue Number: 471093
• Device Lot Number: K10211026 0282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1