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

Model Number 480460

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2018

Event Type  malfunction  

Event Description

On introduction of the stapler, that was not connected to tissue - the stapler locked and the surgeon was unable to move stapler.The dial on top was turned to "engage and release." then 2 buttons on the side were used to aid in the release.The stapler was removed without any issue.

• Brand Name: SUREFORM
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; building 101; sunnyvale CA 94086 5304
• MDR Report Key: 8132429
• MDR Text Key: 129354936
• Report Number: 8132429
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874115640
• UDI-Public: (01)00886874115640
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/30/2018

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: 480460
• Device Lot Number: T10180821
• 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: 11/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22995 DA