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

Model Number JR-STE25-2.0-6

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem Perforation (2001)

Event Date 02/22/2021

Event Type  Injury  

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 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
• Type of Device: SURGICAL STAPLER
• Manufacturer (Section D): BOLDER SURGICAL; 331 s 104th st.; ste 200; louisville CO 80027 9717
• Manufacturer (Section G): BOLDER SURGICAL; 331 s 104th s; ste 200; louisville CO 80027 9717
• Manufacturer Contact: brad greathouse ; 331 s 104th st; ste 200; louisville, CO 80027-9717 ; 9792270102
• MDR Report Key: 11569112
• MDR Text Key: 242483093
• Report Number: 3010377594-2021-00002
• Device Sequence Number: 1
• Product Code: GAG
• UDI-Device Identifier: 00865163000102
• UDI-Public: (01)00865163000102(17)220213(10)75BJ1305
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2.5 YR
• Patient Weight: 14