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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JUSTRIGHT SURGICAL JUSTRIGHT 5MM STAPLER

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JUSTRIGHT SURGICAL JUSTRIGHT 5MM STAPLER Back to Search Results
Model Number JR-ST25-2.0
Device Problems Use of Device Problem (1670); Failure to Form Staple (2579)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 08/17/2016
Event Type  Injury  
Manufacturer Narrative

No root cause could be determined because the device has not been returned for evaluation. Should the device become available, the file will be re-opened and the investigation summary amended as appropriate. We reviewed the manufacturing lot release information and confirmed this lot passed the functional acceptance criteria as specified in the stapler and reload production quality plan, including staple formation. Device not returned for evaluation.

 
Event Description

On (b)(6) , the surgeon was performing a left lower lobectomy on a (b)(6) mo old patient. The case had started laparoscopically but had converted to open prior to use of the justright device(s), so there was no video of the event. He applied the jaws to the hylum of the pulmonary vein, which was approximately 1cm wide. He could not recall how he closed the jaws. He could not verify that he clamped the white clamp lever prior to firing the staples. He started to fire by reaching for the blue fire trigger lever and "could feel something wasn't right. " the senior scrub guided him to stop in the middle of firing as she perceived he was using it incorrectly. He removed the stapler from the tissue, stating that he didn't think it layed down any staples and that it was hard to get the device off of the tissue. He clamped the vein with a hemostat. We cannot confirm if there was any bleeding at this time. He and the staff reviewed the stapler setup sheet with operating instructions that had previously been provided by justright. He opened a new device. When he fired the second device, some staples crimped, some were still straight. The vein hemorrhaged once the hemostat was removed. Clips were used to stop the bleeding. Patient was released from icu a week later. No indication that this event resulted in admission to icu. Justright surgical has requested the device be returned three times, but the hospital has indicated they will not presently return the device.

 
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Brand NameJUSTRIGHT 5MM STAPLER
Type of DeviceJUSTRIGHT 5MM STAPLER
Manufacturer (Section D)
JUSTRIGHT SURGICAL
357 mccaslin blvd
suite 120
louisville CO 80027 2949
Manufacturer Contact
claire bronstein
357 mccaslin blvd
suite 120
louisville, CO 80027-2949
7202877146
MDR Report Key6023719
MDR Text Key57250988
Report Number3010377594-2016-00001
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK132472
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 10/12/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/12/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date04/07/2017
Device MODEL NumberJR-ST25-2.0
Device Catalogue NumberJR-ST25-2.0-6
Device LOT Number75DF0614
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/29/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/07/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/12/2016 Patient Sequence Number: 1
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