MAUDE Adverse Event Report: JUSTRIGHT SURGICAL JUSTRIGHT 5MM STAPLER; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Model Number JR-ST25-2.0-6

Device Problem Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation concluded that, based on information provided by the surgeon, the device was used out of sequence.

Event Description

The surgeon was performing a laparoscopic cholecystectomy to close a large cystic duct.He reported that the stapler cut the tissue and fired staples but they were unformed.The surgeon hand sutured the cystic stump.The patient recovered normally.Patient information was requested but not provided.The device was disposed of by the hospital and could not returned for investigation.

• Brand Name: JUSTRIGHT 5MM STAPLER
• Type of Device: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): JUSTRIGHT SURGICAL; 331 s. 104th st. suite 200; louisville CO 80027
• Manufacturer Contact: deborah pacheco ; 331 s. 104th st. suite 200; louisville, CO 80027 ; 7202877134
• MDR Report Key: 8524872
• MDR Text Key: 145787821
• Report Number: 3010377594-2019-00004
• Device Sequence Number: 1
• Product Code: GAG
• UDI-Device Identifier: 10865163000109
• UDI-Public: 10865163000109
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2021
• Device Model Number: JR-ST25-2.0-6
• Device Catalogue Number: JR-ST25-2.0-6
• Device Lot Number: 75BI0418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2019
• 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