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

Model Number JR-ST25-2.0

Device Problem Difficult to Open or Close (2921)

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

Event Date 03/10/2020

Event Type  malfunction  

Event Description

Stapler fired and it did not close completely on the appendix.The stapler also did not open correctly making it hard to remove the stapler from the patient.All staples were removed.

• 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: 9915893
• MDR Text Key: 186141250
• Report Number: 9915893
• 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: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: JR-ST25-2.0
• Device Catalogue Number: JR-ST25-2.0
• Device Lot Number: 75K10506
• 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: 03/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1