MAUDE Adverse Event Report: JUSTRIGHT SURGICAL / BOLDER SURGICAL, LLC JUST RIGHT 5MM STAPLER 12 MM; STAPLER, SURGICAL

Model Number 00865163000102

Device Problem Failure to Form Staple (2579)

Patient Problem Failure to Anastomose (1028)

Event Date 08/09/2020

Event Type  malfunction  

Event Description

Staple line did not seal when using for appy.Fda safety report id# (b)(4).

• Brand Name: JUST RIGHT 5MM STAPLER 12 MM
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): JUSTRIGHT SURGICAL / BOLDER SURGICAL, LLC; louisville CO 80027
• MDR Report Key: 10546271
• MDR Text Key: 207537799
• Report Number: MW5096700
• Device Sequence Number: 1
• Product Code: GAG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2022
• Device Model Number: 00865163000102
• Device Lot Number: 75BJ1305
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12 YR