MAUDE Adverse Event Report: JUSTRIGHT SURGICAL JUSTRIGHT 5MM STAPLER

Model Number JR-ST25-2.0-6

Device Problem Failure to Fire (2610)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/17/2018

Event Type  malfunction  

Manufacturer Narrative

On 10/5/2018: the stapler handle was returned to justright surgical with broken and missing components.There is evidence that the device was fired out of sequence.Should new information become available, the file will be re-opened, and the investigation summary amended.

Event Description

During a left thoracotomy, about an hour after the incision, on a lower lobectomy wedge for pulmonary sequestration on an 8.2 kg patient there were 2 misfires.The misfires caused the pulmonary artery to bleed.They opened multiple reloads to finish case.The patient is fine.

• Brand Name: JUSTRIGHT 5MM STAPLER
• Type of Device: JUSTRIGHT 5MM STAPLER
• Manufacturer (Section D): JUSTRIGHT SURGICAL; 331 s 104th st; ste 200; louisville CO 80027
• Manufacturer (Section G): JUSTRIGHT SURGICAL; 331 s 104th st; ste 200; louisville CO 80027
• Manufacturer Contact: claire bronstein ; 331 s 104th st; ste 200; louisville, CO 80027 ; 7202877146
• MDR Report Key: 7964972
• MDR Text Key: 123821247
• Report Number: 3010377594-2018-00005
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2019
• Device Model Number: JR-ST25-2.0-6
• Device Catalogue Number: JR-ST25-2.0-6
• Device Lot Number: 75LG0430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Date Manufacturer Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2017
• 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
• Patient Weight: 8