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

Model Number	JR-ST25-2.0
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for lot 75ga4605 was reviewed.No anomalies were noted on the lot release paperwork.The device was returned for investigation.The investigation team was able to replicate the reported issue by firing the stapler onto a hard plastic material.This indicates that the drive mechanism within the reload and handle system experienced much higher than normal resistance during the firing process.The handles functioned properly without reloads attached so the resistance did not come from the handles.The root cause of the reported incident could not be conclusively determined.The potential root causes are high resistance to the firing motion from the reload or tissue/material in the jaws as indicated by the separation observed at the seam between the two handle shells.
Event or Problem Description
It was reported that during a laparoscopic nephrectomy during the stapler firing on renal hilum tissue, a loud crunch noise was heard.Un-crimped staples were observed along the staple line.The patient was less than 18 years of age, but no further patient information was provided.

• 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: 13237268
• Report Number: 3010377594-2022-00001
• Device Sequence Number: 4599037
• Product Code: GAG
• UDI-Device Identifier: 00865163000102
• UDI-Public: 0100865163000102172308311075GA4605
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2022

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: 08/31/2023
• Device Model Number: JR-ST25-2.0
• Device Catalogue Number: JR-ST25-2.0
• Device Lot Number: 75GA4605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2021
• 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: Unknown