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

Model Number	JR-ST25-2.0
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Bronchial Hemorrhage (4456)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for lot 75da2823 was reviewed.No anomalies were noted on the lot release paperwork.Reload device was returned for investigation, and the complaint was confirmed.It is possible the stapler was fired on too thick or tough tissue, but this could not be confirmed.Observation of the knife blade appears to indicate the reload was fired over another staple line, but the surgeon stated that this was not the case.The current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Event or Problem Description
It was reported that the surgeon identified malformed staples on the right side of the cut line near the distal tip of the staple line.Patient information was not provided.Patient impact was additional surgical intervention.The patient has now recovered and has been discharged.The disposable stapler handle was disposed of an was not available for return, but the reload used during the event was returned for investigation.

• 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: 13044205
• Report Number: 3010377594-2021-00010
• Device Sequence Number: 20195979
• Product Code: GAG
• UDI-Device Identifier: 00865163000102
• UDI-Public: 0100865163000102172304281075DA2823
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2021

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: 04/28/2023
• Device Model Number: JR-ST25-2.0
• Device Catalogue Number: JR-ST25-2.0
• Device Lot Number: 75DA2823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2021
• 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: Required Intervention
• Patient Sex: Female