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

Model Number JR-ST25-2.0-6

Device Problem Firing Problem (4011)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2019

Event Type  malfunction  

Manufacturer Narrative

One used reload was received on 3/27/2019.It was examined and there was evidence of staple travel and several indications that staples were deployed.The reload anvil opened when the top lever was raised.The anvil was examined under a microscope and staple travel was confirmed.During manufacturing, the staple cartridge is confirmed to contain all staples at three different checkpoints.Based on the returned device investigation, it was determined that there was no device malfunction.The investigation findings are indicative of tissue that is too thick or the device is not clamped appropriately on the tissue.

Event Description

The surgeon reported that, during a laparoscopic appendectomy, the stapler cut and appeared to fire but no staples were deployed.The doctor did not visibly see any staples in the tissue.The stapler appeared to fire normally and there were no atypical noises.The cecum was open on the far side and then "zippered" open all the way.He placed an endoloop on the stump of the cecum.There was nothing out of the ordinary in the appendix pathology, which indicated appendicitis.The patient experienced no adverse effects.The surgeon was unable to provide patient gender when requested.

• 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: 8501827
• MDR Text Key: 141622386
• Report Number: 3010377594-2019-00003
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JR-ST25-2.0-6
• Device Catalogue Number: JR-ST25-2.0-6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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: 14 YR
• Patient Weight: 64