MAUDE Adverse Event Report: JUSTRIGHT SURGICAL JUSTRIGHT 5MM STAPLER

Model Number JR-ST25-2.0-6

Device Problems Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)

Patient Problems Abdominal Pain (1685); Patient Problem/Medical Problem (2688)

Event Date 09/25/2017

Event Type  malfunction  

Manufacturer Narrative

When this complaint was received/investigated it was determined that the protruding cam blade was a result of the torque that was applied by the surgeon when trying to remove the device from the cannula.When a second complaint of the same nature, from the same physician, was received, there was not the same amount of damage to components.Jrs suspected that the reload caught on the end of a bent reusable cannula.The problem was reproduced once but is not repeatable.

Event Description

During a laparoscopic appendectomy, a justright 5mm stapler was used in conjunction with a storz 5mm metal cannula.The stapler fired according to specifications and all staples formed properly.When removing the stapler, the surgeon had trouble removing the device from the cannula.As the device was removed, the surgeon noticed damage to the cartridge.The surgery was completed, and the patient was fine.

• Brand Name: JUSTRIGHT 5MM STAPLER
• Type of Device: JUSTRIGHT 5MM STAPLER
• Manufacturer (Section D): JUSTRIGHT SURGICAL; 331 s 104th st; ste 200; louisville CO 80027
• Manufacturer Contact: claire bronstein ; 331 s 104th st; ste 200; louisville, CO 80027 ; 7202877146
• MDR Report Key: 7956880
• MDR Text Key: 123517460
• Report Number: 3010377594-2018-00004
• 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: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2019
• Device Model Number: JR-ST25-2.0-6
• Device Catalogue Number: JR-ST25-2.0-6
• Device Lot Number: 75FG2008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2017
• 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 Age: 6 YR
• Patient Weight: 35