MAUDE Adverse Event Report: JUSTRIGHT SURGICAL JUSTRIGHT 5MM STAPLER; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Model Number JR-ST25-2.0-6

Device Problem Firing Problem (4011)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

The device history record (dhr) could not be reviewed since the lot number was not provided.The device was not returned by the hospital.Pictures from the surgery were provided.The images show several pieces of tissue caught on a staple.The images don't provide sufficient information to determine if the staple was loose or at the end of the staple line.No conclusion about staple formation during the initial surgery can be made.Based on the information provided, no root cause can be determined.

Event Description

The customer reported an obstruction after an appendectomy.Date of the surgery was not provided.The surgeon believed the obstruction was caused by a loose or partially attached underformed staple.The patient had to come back to the hospital but it is unknown what specific treatment was done to unknot the tissue.Patient information was requested but not provided by the hospital.The device was not available since the incident happened several months prior to the hospital reporting it.

• Brand Name: JUSTRIGHT 5MM STAPLER
• Type of Device: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): JUSTRIGHT SURGICAL; 331 s. 104th st.; suite 200; louisville CO 80027
• Manufacturer Contact: deborah pacheco ; 331 s. 104th st.; suite 200; louisville, CO 80027 ; 7202877134
• MDR Report Key: 9147579
• MDR Text Key: 162105458
• Report Number: 3010377594-2019-00007
• Device Sequence Number: 1
• Product Code: GAG
• UDI-Device Identifier: 10865163000109
• UDI-Public: 10865163000109
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: JR-ST25-2.0-6
• Device Catalogue Number: JR-ST25-2.0-6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention