MAUDE Adverse Event Report: JUSTRIGHT SRGICAL JUSTRIGHT 5MM STAPLER

Model Number JR-ST25-2.0-6

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

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

Event Date 06/21/2018

Event Type  malfunction  

Manufacturer Narrative

On 7/19/2018 - the analysis is pending.

Event Description

During an appendectomy, the justright 5mm stapler was used in conjunction with a storz 5mm metal reusable 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, it appeared that a component got stuck on the cannula, causing damage to the cartridge.

Manufacturer Narrative

On 8/17/18 evaluation summary: a review of the device history record for this lot indicates the product met all specifications at the time of manufacture release.All parts of the reload and staple handle measured were within specification.It was not possible to duplicate this complaint in the laboratory.It is possible that the cannula used during the procedure played a role in the malfunction of the device.Should new information become available, the file will be re-opened and the investigation summary amended.

• Brand Name: JUSTRIGHT 5MM STAPLER
• Type of Device: JUSTRIGHT 5MM STAPLER
• Manufacturer (Section D): JUSTRIGHT SRGICAL; 331 s. 104th street; suite 200; louisville CO 80027
• MDR Report Key: 7794094
• MDR Text Key: 123681174
• Report Number: 3010377594-2018-00002
• Device Sequence Number: 1
• Product Code: GAG
• UDI-Device Identifier: 10865163000109
• UDI-Public: 10865163000109
• Combination Product (y/n): N
• PMA/PMN Number: K132472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2019
• Device Model Number: JR-ST25-2.0-6
• Device Catalogue Number: JR-ST25-2.0-6
• Device Lot Number: 75LG0430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Date Manufacturer Received: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Weight: 35