MAUDE Adverse Event Report: JUSTRIGHT SURGICAL JUSTRIGHT 5MM STAPLER

Model Number JR-ST25-2.0

Device Problems Use of Device Problem (1670); Failure to Form Staple (2579)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/17/2016

Event Type  Injury  

Manufacturer Narrative

No root cause could be determined because the device has not been returned for evaluation.Should the device become available, the file will be re-opened and the investigation summary amended as appropriate.We reviewed the manufacturing lot release information and confirmed this lot passed the functional acceptance criteria as specified in the stapler and reload production quality plan, including staple formation.Device not returned for evaluation.

Event Description

On (b)(6) , the surgeon was performing a left lower lobectomy on a (b)(6) mo old patient.The case had started laparoscopically but had converted to open prior to use of the justright device(s), so there was no video of the event.He applied the jaws to the hylum of the pulmonary vein, which was approximately 1cm wide.He could not recall how he closed the jaws.He could not verify that he clamped the white clamp lever prior to firing the staples.He started to fire by reaching for the blue fire trigger lever and "could feel something wasn't right." the senior scrub guided him to stop in the middle of firing as she perceived he was using it incorrectly.He removed the stapler from the tissue, stating that he didn't think it layed down any staples and that it was hard to get the device off of the tissue.He clamped the vein with a hemostat.We cannot confirm if there was any bleeding at this time.He and the staff reviewed the stapler setup sheet with operating instructions that had previously been provided by justright.He opened a new device.When he fired the second device, some staples crimped, some were still straight.The vein hemorrhaged once the hemostat was removed.Clips were used to stop the bleeding.Patient was released from icu a week later.No indication that this event resulted in admission to icu.Justright surgical has requested the device be returned three times, but the hospital has indicated they will not presently return the device.

• Brand Name: JUSTRIGHT 5MM STAPLER
• Type of Device: JUSTRIGHT 5MM STAPLER
• Manufacturer (Section D): JUSTRIGHT SURGICAL; 357 mccaslin blvd; suite 120; louisville CO 80027 2949
• Manufacturer Contact: claire bronstein ; 357 mccaslin blvd; suite 120; louisville, CO 80027-2949 ; 7202877146
• MDR Report Key: 6023719
• MDR Text Key: 57250988
• Report Number: 3010377594-2016-00001
• Device Sequence Number: 1
• Product Code: GAG
• UDI-Device Identifier: 00865163000102
• UDI-Public: 00865163000102
• 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: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/07/2017
• Device Model Number: JR-ST25-2.0
• Device Catalogue Number: JR-ST25-2.0-6
• Device Lot Number: 75DF0614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2016
• 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 Age: 9 MO
• Patient Weight: 11