MAUDE Adverse Event Report: ENDOAID LTD ENDORINGS DEVICE

Model Number E101

Device Problems Detachment of Device or Device Component (2907); Compatibility Problem (2960)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2015

Event Type  Injury  

Event Description

The endorings device is intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following: keeping the suitable depth of endoscopic field of view.The user reported the endorings device became detached from the endoscope near the sigmoid colon.The physician retrieved the device with a raptor grasping device.There was a delay in procedure of approximately 3-5 minutes for the retrieval.There was no harm to the pt as a result of the device retrieval.The user also reported the endorings device had a detached from the endoscope because the wrong size device (too large) had been selected for use with the endoscope (fuji model #ec-530ls2).There was no report of product defect or malfunction.The device was disposed of after retrieval.

Manufacturer Narrative

This event was previously reported to fda on 06/05/2015, via the medwatch voluntary reporting process (3010704463-2015-00001).As the device manufacturer, endoaid understands that its report should have been submitted per the mandatory medical device reporting requirements.Therefore, this report is being resubmitted to fda again following the correct procedures.Endorings adult model e101 was assembled on a pediatric scope not according to ifu instructions.Endorings adult model e101 fit on the pediatric scope was too loose which resulted in its detachment from the scope during the procedure.The endorings was retrieved easily, no damage or additional discomfort to the pt.Preventive action: repeated in-service in the facility by a product specialist.

• Brand Name: ENDORINGS DEVICE
• Type of Device: ENDORINGS
• Manufacturer (Section D): ENDOAID LTD; 43 haeshel st; caesarea 38900 ; EI 38900
• Manufacturer Contact: meytal segev ; 43 haeshel st; caesarea 38900 ; IS 38900 ; 4623901EXT
• MDR Report Key: 4890730
• MDR Text Key: 6071576
• Report Number: 3010704463-2015-00001
• Device Sequence Number: 1
• Product Code: FED
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: E101
• Device Catalogue Number: E101
• Device Lot Number: 10100019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/21/2015
• 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): Required Intervention