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

Model Number JR-ST25-2.0-6

Device Problem Entrapment of Device (1212)

Patient Problem Obstruction/Occlusion (2422)

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

No root cause could be determined because the device was not available for evaluation.Justright surgical spoke with the surgeon regarding the initial surgery.The doctor indicated that he was unsure if he held the jaws shut for 30 seconds before firing the stapler.However, he inspected the staple line intra-operatively and believed all staples were fully formed.He also indicated that he might have tried to separate the wisp of tissue left at the end of the staple line by pulling with the stapler, instead of cutting it.That action may result in a pulled/open staple at the end of the staple line.Subsequent discussion with the surgeon during follow-up indicated that the bowel obstruction was caused by a mesentery stricture due to a staple that "snagged" on a piece of mesentery.

Event Description

A laparoscopic appendectomy was performed (b)(6) 2018 on a (b)(6) old male.On (b)(6) 2018 the patient presented with a bowel obstruction.The appendix end colon mesentery created an obstructing band across the ileum.A second laparoscopic surgery was completed on (b)(6) 2018 to clear the bowel obstruction.

• Brand Name: JUSTRIGHT 5MM STAPLER
• Type of Device: SURGICAL STAPLER
• Manufacturer (Section D): JUSTRIGHT SURGICAL; 331 s 104th st; ste 200; louisville CO 80027
• Manufacturer (Section G): 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: 8215447
• MDR Text Key: 132038687
• Report Number: 3010377594-2018-00009
• 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: 01/02/2019

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
• Device Operator: Health Professional
• Device Model Number: JR-ST25-2.0-6
• Device Catalogue Number: JR-ST25-2.0-6
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 01/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 5 YR
• Patient Weight: 15