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

Model Number	JR-STE25-2.0-6
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record (dhr) for lot 75bj1305 was reviewed.No anomalies were noted on the lot release paperwork.The incident unit was returned for evaluation.The evaluation confirmed a broken firing lever, cracked cartridge housing, and leading cam side staple protrusion.These are indicative of reload jamming.The incidence of reload jamming is rare.
Event or Problem Description
It was reported that during a thoracoscopy procedure, the handle of the stapler broke apart while the surgeon was compressing tissue, to staple the lung.The anvil was stuck in a closed position and the surgeon had to manually pry open the jaws.The procedure was completed using clips to stop the bleeding.There were no reported additional patient impacts.

• Brand Name: JUSTRIGHT 5MM STAPLER
• Common Device Name: SURGICAL STAPLER
• Manufacturer (Section D): BOLDER SURGICAL; 331 s 104th st.; ste 200; louisville CO 80027 9717
• MDR Report Key: 11569112
• Report Number: 3010377594-2021-00002
• Device Sequence Number: 19732601
• Product Code: GAG
• UDI-Device Identifier: 00865163000102
• UDI-Public: (01)00865163000102(17)220213(10)75BJ1305
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/25/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/13/2022
• Device Model Number: JR-STE25-2.0-6
• Device Catalogue Number: JR-STE25-2.0-6
• Device Lot Number: 75BJ1305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2.5 YR
• Patient Weight: 14