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

Model Number 480460

Device Problems Misfire (2532); Mechanical Jam (2983); Physical Resistance/Sticking (4012)

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

Event Date 08/07/2020

Event Type  malfunction  

Event Description

From staff: during a robotically-assisted gastric sleeve procedure, the xi 60 sureform stapler jammed mid-staple.A second stapler was obtained, and the procedure was successfully completed using the second stapler.From op report: a 40 french bougie was passed trans-orally into the stomach.It was placed against the lesser curvature of the stomach.The major portion of the stomach was then removed with subsequent firing of the robotic stapler.An initial green load was used followed by subsequent firings of a blue load.With approximately 2 staple load fires remaining blue loaded stapler was placed in the position against the bougie.The stapler did not fire correctly.It appeared that a staple was stuck within the trach next to the blade causing s stable or to inaccurate early since the tissue.After a few cm the stapler was unclamped and was removed from the field.I inspected the area and was successfully able to come inside of this malfunction stable on against the boogie.Subsequent stable firings were then used to finish the transection.Manufacturer response for staple, implantable, sureform (per site reporter).Asked us to keep device for examination.Rep will ask to be shipped back at a later date.Manufacturer response for system, surgical, computer controlled instrument, sureform (per site reporter) manufacturer asked us to keep device for examination.They will request at a later date.

• 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: 10419535
• MDR Text Key: 203299721
• Report Number: 10419535
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2020

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: L91200322
• 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: 08/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16425 DA
• Patient Weight: 124