MAUDE Adverse Event Report: JUSTRIGHT SURGICAL, LLC JUSTRIGHT 5MM STAPLER; STAPLER, SURGICAL

Model Number	JR-ST25-2.0
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A disposable laparoscopic stapler was opened for patient's thorascopic lung surgery.The stapler load that came with the stapler failed to fire any staples.No harm came from the attempt of use.Another stapler load was opened and used with the originally opened stapler handpiece without issue.Manufacturer response for stapler, surgical, just right 5 mm stapler (per site reporter).

• Brand Name: JUSTRIGHT 5MM STAPLER
• Common Device Name: STAPLER, SURGICAL
• Manufacturer (Section D): JUSTRIGHT SURGICAL, LLC; 357 s. mccaslin blvd ste 120; louisville CO 80027
• MDR Report Key: 8365853
• Report Number: 8365853
• Device Sequence Number: 19232385
• Product Code: GAG
• UDI-Device Identifier: 00865163000102
• UDI-Public: (01)00865163000102
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/10/2018
• Report Date (Section F): 02/12/2019

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
• Operator of Device: Health Professional
• Device Model Number: JR-ST25-2.0
• Device Catalogue Number: JR-ST25-2.0
• Device Lot Number: 75DH0900
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 8
• Date Report Sent to FDA: 02/12/2019