MAUDE Adverse Event Report: BOLDER SURGICAL JUSTRIGHT 5MM STAPLER; SURGICAL STAPLER

Model Number	JR-ST25-2.0
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned with the reload attached, and investigation was completed.Inspection of the device as received determined that the green safety was held down beyond its normal position during the firing stage in the stapling process, causing the safety mechanism to break and impede the proper motion of the firing lever, resulting in inability to open the anvil.To ensure proper staple formation and tissue cutting, the device is designed to require complete staple deployment before the anvil can be opened and tissue removed from the jaws.
Event or Problem Description
It was reported that during stapler use, there was a large crack when the stapler was fired.Following this, the customer was unable to release the stapler from the tissue.Additional port was added to cut out the portion of the vessel with the stapler attached.The stapler was then removed along with the clamped tissue.

• Brand Name: JUSTRIGHT 5MM STAPLER
• Common Device Name: SURGICAL STAPLER
• Manufacturer (Section D): BOLDER SURGICAL; 331 south 104 street; ste 200; louisville CO 80027 9717
• Manufacturer (Section G): BOLDER SURGICAL; 331 south 104 street; ste 200; louisville CO 80027 9717
• Manufacturer Contact: brad greathouse ; 331 south 104 street; ste 200; louisville, CO 80027-9717 ; 9792270102
• MDR Report Key: 13430156
• Report Number: 3010377594-2022-00002
• Device Sequence Number: 4304729
• Product Code: GAG
• UDI-Device Identifier: 00865163000102
• UDI-Public: 0100865163000102172309081075HA5509
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K132472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2023
• Device Model Number: JR-ST25-2.0
• Device Catalogue Number: JR-ST25-2.0
• Device Lot Number: 75HA5509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2022
• Initial Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 MO
• Patient Sex: Male