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

Model Number 470298

Device Problem Mechanical Jam (2983)

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

Event Date 02/28/2022

Event Type  malfunction  

Event Description

Surgeon did not have 100% clamp, pa pulled stapler and it locked on tissue, needed to manually open with xi stapler release kit.Manufacturer response for xi robot 45 stapler, (brand not provided) (per site reporter) issued rga# (b)(4), send shipping label.

• 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: 15469862
• MDR Text Key: 300440943
• Report Number: 15469862
• 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: 09/15/2022

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 Model Number: 470298
• Device Catalogue Number: 470298
• Device Lot Number: T10200917 0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Sex: Male