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

Model Number JR-ST25-2.0

Device Problem Misfire (2532)

Patient Problem No Code Available (3191)

Event Date 05/07/2020

Event Type  malfunction  

Event Description

Patient was undergoing a laparoscopic procedure for the placement of a gastrostomy tube.The surgical stapler misfired when used during the procedure.A different device was needed to continue the surgical procedure.The patient had to have the size of one of the laparoscopic ports upsized to accommodate the different device.

• Brand Name: JUSTRIGHT 5MM STAPLER
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): JUSTRIGHT SURGICAL, LLC; 331 s. 104th street suite 200; louisville CO 80027
• MDR Report Key: 10074248
• MDR Text Key: 191558840
• Report Number: 10074248
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JR-ST25-2.0
• Device Catalogue Number: JR-ST25-2.0
• Device Lot Number: 75II1854
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5475 DA
• Patient Weight: 46