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 Problems Cyst(s) (1800); No Consequences Or Impact To Patient (2199)

Event Date 01/03/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.

Event Description

Medwatch (b)(4) description of event: stapler loaded by scrub, tested prior to entry into port by surgeon, placed into port, fired, jaws opened to stapler enough for tissue to fall from stapler, #5 button in the back of the stapler did not open fully, surgeon pulled stapler back recoiled and a hole occurred in the diaphragm.The opening was sutured intraoperatively.The patient remained hemodynamically stable throughout.The device was unable to be evaluated since the hospital declined to return it.

Manufacturer Narrative

Additional information was anticipated to be received on 02/18/19.No additional information was obtained from hospital personnel.

• 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
• MDR Report Key: 8328822
• MDR Text Key: 138147298
• Report Number: 3010377594-2019-00001
• 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: other
• Type of Report: Initial,Followup
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Model Number: JR-ST25-2.0-6
• Device Catalogue Number: JR-ST25-2.0-6
• Device Lot Number: 75DH3021
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 DA
• Patient Weight: 3