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

Model Number	JR-ST25-2.0
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for investigation purposes, the findings are as follows: jr stapler disposable received and tested: visual inspection was performed, and the cartridge appeared as it was fired, pushers were visible and the knife was in forward position.The handle green safety lock was broken.A different cartridge was attempted to be used on the device, but the cam was stuck and could not be retracted since it was not aligned.The complaint could not be confirmed due to the cam and pusher misaligned so no testing could be performed on the device.This observation will be monitored and trended.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.
Event or Problem Description
It was reported that during a procedure on (b)(6) 2022 during a surgery the just righ 5 mm stapler was being used as indicated , the stapler made a sound then puncture a structure which caused the patient to bleed.The stapler was placed around the inferior pulmonary vein and when the stapler was released it became clear that the staples had not closed and the stapler had cut a hole in the inferior pulmonary vein which caused the bleeding.Due to this event the emergent gasping and a venotomy was performed , then clips were used to reinforce with a silk tie.The vein was only partially transected and there was some debris from the staple in the body after firing.The patient is a 12 months old male 10 kg.The patient is doing fine.No other information is available.

• Brand Name: JUSTRIGHT 5MM STAPLER
• Common Device Name: STAPLER, SURGICAL
• Manufacturer (Section D): BOLDER SURGICAL; 331 south 104 street; ste 200; louisville CO 80027
• Manufacturer (Section G): BOLDER SURGICAL; 331 south 104 street; ste 200; louisville CO 80027
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose, alajuela 20102- CRI ; CS 20102 CRI
• MDR Report Key: 15205022
• Report Number: 3010377594-2022-00027
• Device Sequence Number: 2123352
• Product Code: GAG
• UDI-Device Identifier: 00865163000102
• UDI-Public: (01)00865163000102(10)75LJ0123(17)221202
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2022

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: 12/02/2022
• Device Model Number: JR-ST25-2.0
• Device Catalogue Number: JR-ST25-2.0
• Device Lot Number: 75LJ0123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2020
• 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