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

Model Number	JR-ST25-2.0
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	04/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A preliminary investigation revealed the following : visual inspection of devices did not have any obvious damage.The anvil on two of the three reloads were elevated slightly.The handle did not have any trouble moving through all steps and functioned as intended.Reloads were able to attach and detach from the handle as intended.New staple lines were loaded into the attached stapler.When deployed there was no evidence of malformed or under formed staples.Device pending to be returned for formal investigation.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.
Event or Problem Description
It was reported that during a just right stapler procedure on (b)(6) 2025, the physician reported that the physician was not satisfied with the staple line that was deployed and that he used another modality to seal the tissue.Physician reported that the line fell apart after deploying.No patient injury was reported and no medical intervention reported.A image was provided in which it was observed that the tissue that was being stapled was the bile duct.Per instructions for use it is not recommended to use the stapler on bile duct as the use in that tissue can be destructive.This was an off-label use.
Additional Manufacturer Narrative
Device was returned for investigational purposes: visual inspection was conducted on the stapler and reload, and there were no signs of physical damage; all the components were in good shape.Functional testing was conducted, and the handle could be properly connected to the reloads, the finger wheel was rotating, and the levers and button were actuated as expected.Just right stapler was used with the three returned reloads, and it could fire the staplers with no issues.The tissue could be cut, and all the staplers were attached to the tissue with no malformations.Hence, the complaint cannot be confirmed.This observation will be monitored and trended.

• Brand Name: JUSTRIGHT¿ STAPLER 5 MM
• Common Device Name: STAPLER, SURGICAL
• Manufacturer (Section D): BOLDER SURGICAL; 331 south 104 street; suite 200; louisville CO 80027
• Manufacturer (Section G): BOLDER SURGICAL; 331 south 104 street; louisville CO 80027
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102
• MDR Report Key: 22061116
• Report Number: 3010377594-2025-00007
• Device Sequence Number: 7639439
• Product Code: GAG
• UDI-Device Identifier: 00865163000102
• UDI-Public: (01)00865163000102(17)260506(11)240506(10)75DD8111
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/05/2026
• Device Model Number: JR-ST25-2.0
• Device Catalogue Number: JR-ST25-2.0
• Device Lot Number: 75DD8111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2024
• Is the Device Labeled for Single Use? (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: Other
• Patient Sex: Unknown