MAUDE Adverse Event Report: JUSTRIGHT SURGICAL, INC. JUSTRIGHT 5MM STAPLER

Model Number JR-ST25-2.0-6

Device Problem Failure to Fire (2610)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/26/2018

Event Type  malfunction  

Manufacturer Narrative

On 8/2/2018: the analysis is pending.[mw5078296].

Event Description

During a lobectomy on a (b)(6), a stapler was reported to cut but not staple.The patient is fine.

Manufacturer Narrative

(b)(6) 2018 additional information received from user.(b)(6) 2018 evaluation summary: a review of the device history record for this lot indicates the product met all specifications at the time of manufacture release.Upon receipt of the stapler handle and reload, it was observed that the anvil tail had yielded on the reload, the lock release was broken, and only the first three pockets on the proximal end of the anvil had indications of staple travel.These observations combined conclude that the tissue being stapled (bronchus) was either thicker than the recommended range of 0.75 mm to 1.0 mm, and/or the tissue was not allowed time to compress once clamped before firing.

• Brand Name: JUSTRIGHT 5MM STAPLER
• Type of Device: JUSTRIGHT 5MM STAPLER
• Manufacturer (Section D): JUSTRIGHT SURGICAL, INC.; 331 s 104th street ste 200; louisville CO 80027
• Manufacturer (Section G): JUSTRIGHT SURGICAL, INC.; 331 s 104th street ste 200; louisville CO 80027
• Manufacturer Contact: claire bronstein ; 331 s 104th street ste 200; louisville, CO 80027 ; 7202877146
• MDR Report Key: 7844239
• MDR Text Key: 123821395
• Report Number: 3010377594-2018-00003
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2020
• Device Model Number: JR-ST25-2.0-6
• Device Catalogue Number: JR-ST25-2.0-6
• Device Lot Number: 75CH0505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Date Manufacturer Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2018
• 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
• Patient Age: 22 MO