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	04/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.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.
Event or Problem Description
It was reported that during a just right stapler procedure on april 7th 2025, the physician reported that the stapler had misfired during a bladder fistula repair on a pediatric patient.The physician applied adequate compression beforehand fired on the fistula, and when they opened the jaws there was an open hole and no staples had been applied to the tissue.Thus it cut but it did not form staples.The physician switched to a different instrument to finish the case.Physician reported that due to the angle of the approach she could not visualize the tip of the staple to confirm parallel jaws before firing.She noted that it was appropriately thin tissue.No patient injury was reported and no medical intervention was required.No other information available.

• 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; suite 200; louisville CO 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102 ; CR 20102
• MDR Report Key: 22145696
• Report Number: 3010377594-2025-00009
• Device Sequence Number: 7424942
• Product Code: GAG
• UDI-Device Identifier: 00865163000102
• UDI-Public: 00865163000102
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 06/04/2025

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-ST25-2.0
• Device Catalogue Number: JR-ST25-2.0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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