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

Model Number 480460

Device Problem Misfire (2532)

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

Event Date 07/08/2021

Event Type  malfunction  

Event Description

The surgeons reported that the stapler did not fire properly.

• Brand Name: SUREFORM
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 12258445
• MDR Text Key: 264506038
• Report Number: 12258445
• 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: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480460
• Device Lot Number: L92210510
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA