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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for lot 75cj2515 was reviewed.No anomalies were noted on the lot release paperwork.The device was not returned, without a product return, no product evaluation is able to be conducted.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 during the procedure the surgeon stapled the bronchus but said the staples did not form into b's.The surgeon sewed over the staple line to complete the case.There were no reported patient impacts.

• 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
• MDR Report Key: 12661091
• Report Number: 3010377594-2021-00008
• Device Sequence Number: 4298812
• Product Code: GAG
• UDI-Device Identifier: 00865163000102
• UDI-Public: (01)00865163000102(17)220326(10)75CJ2515
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2021

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 Expiration Date: 03/26/2022
• Device Model Number: JR-ST25-2.0
• Device Catalogue Number: JR-ST25-2.0
• Device Lot Number: 75CJ2515
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 MO
• Patient Weight: 7