MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. ARTICULATOR INJECTION NEEDLE

Model Number 00711807

Device Problem Retraction Problem (1536)

Patient Problem Injury (2348)

Event Date 12/10/2015

Event Type  Injury  

Manufacturer Narrative

The articulator injection needle was designed to be used for the injection of various types of media through flexible endoscopes.Us endoscopy received a report from a distributor in the (b)(6) regarding an incident involving an articulator injection needle.According to the report after using the needle, the nurse pulled the handle of the device to retract the needle into the sheath.The device was removed from the endoscope and the needle was still deployed resulting in a sharps injury to the physician.The physician cleaned the wound and checked the history of the patient which was low risk; therefore the physician did not seek further treatment.The event did not result in any harm to the patient.The subject device was not returned for evaluation.The manufacturing record for the device was reviewed and found no manufacturing or quality problems, all inspections were completed and acceptable results were documented.In communication with the user facility, it was discovered that in their practices, they do not visually confirm the retraction of needles prior to removing them from the scope.The ifu cautions, "the spring-loaded handle assists in needle retraction; however, always visually check the retraction as well." the user site was provided training as a result.Device not returned.

Event Description

The articulator injection needle was designed to be used for the injection of various types of media through flexible endoscopes.Us endoscopy received a report from a distributor in the (b)(6) regarding an incident involving an articulator injection needle.According to the report after using the needle, the nurse pulled the handle of the device to retract the needle into the sheath.The device was removed from the endoscope and the needle was still deployed resulting in a sharps injury to the physician.The physician cleaned the wound and checked the history of the patient which was low risk; therefore the physician did not seek further treatment.The event did not result in any harm to the patient.

• Brand Name: ARTICULATOR INJECTION NEEDLE
• Type of Device: INJECTION NEEDLE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer Contact: michael oleksa ; 5976 heisley rd; mentor, OH 44060 ; 4403586263
• MDR Report Key: 5366315
• MDR Text Key: 35963424
• Report Number: 1528319-2016-00001
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K924102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/31/2018
• Device Model Number: 00711807
• Device Catalogue Number: 00711807
• Device Lot Number: 1511515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2015
• 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): Other
• Patient Age: 80 YR