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

Model Number	JR-REL25-2.0-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, the physician reported that during a justright stapler procedure the staple line did not fully deploy after clamping the tissue and firing the staple line.Physician reported that about half of the staple line had deployed and a couple of the staples had not formed.Physician used a second line and observed the same behavior.On a call with a hologic representative it was reported that the tissue looked swollen, the procedure was completed with another modality.No patient injury was reported and no further medical intervention was required.The part that was being treated was the proximal esophagus (zenker´s interparty wall) , and included the cricopharyngeus.No other information available.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
Additional Manufacturer Narrative
During the investigation of the disposable returned by the customer , it was determined that the device returned was the stapler reload (jr-rel25-2.0-12) and not the stapler handpiece.(jr-st25-2.0-6).Visual inspection was conducted, and there were no signs of physical damage.Functional testing was conducted using a different handpiece than the one used by the customer to challenge the reload, and it worked as intended.The staples were deployed as expected and the knife cut the tissue as expected.Hence, the complaint could not be confirmed.This observation will be monitored and trended.The stapler used by the customer was reported under 3010377594-2025-00020.
Additional Manufacturer Narrative
Device investigation was closed on january 29th, 2026.

• Brand Name: JUSTRIGHT¿ STAPLER 5 MM
• Common Device Name: STAPLER,SURGICAL
• Manufacturer (Section D): BOLDER SURGICAL; 36 & 37 apple ridge road; louisville CO 80027
• Manufacturer (Section G): BOLDER SURGICAL; 36 & 37 apple ridge road; suite 200; louisvile CO 80027
• Manufacturer Contact: daniel guevara ; 562 parkwa; coyol free park zone b24; alajuela 20102
• MDR Report Key: 23914419
• Report Number: 3010377594-2025-00021
• Device Sequence Number: 18428791
• Product Code: GAG
• UDI-Device Identifier: 00865163000119
• UDI-Public: (01)00865163000119(17)261212(11)241212(10)75ID4249
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 03/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: JR-REL25-2.0-12
• Device Catalogue Number: JR-REL25-2.0-12
• Device Lot Number: 75ID4249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: Not provided; 01/29/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/10/2026; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2024
• 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
• Patient Sex: Unknown