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

Model Number	JR-ST25-2.0-6
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	03/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a bowel anastomosis on (b)(6) 2025, the physician reported that a stapler was fired in thin and pliable tissue, and when the staple line integrity was checked with saline flow, leaks were observed on both sides of the staple line.The physician changed the modality and used an alternative anastomosis to finish the case.The case was reported as finished successfully and the patient was doing fine.The deice was discarded by the user.No other information could be obtained.
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.

• 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 80027
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102 ; CR 20102
• MDR Report Key: 22308725
• Report Number: 3010377594-2025-00011
• Device Sequence Number: 8568181
• Product Code: GAG
• UDI-Device Identifier: 00865163000102
• UDI-Public: 00865163000102
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: JR-ST25-2.0-6
• Device Catalogue Number: JR-ST25-2.0-6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/23/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown