MAUDE Adverse Event Report: ENDOCHOICE INC. AUTOBAND LIGATOR; LIGATOR, ESOPHAGEAL

Model Number DBL-293

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2014

Event Type  malfunction  

Event Description

It was reported by a distributor that a medical facility was using an autoband ligator to perform ligation on a patient with internal hemorrhoids.The ligator was attached to a gastroscope for the procedure.During the procedure, the barrel assembly of the ligator partially separated from the elastomer gasket used to attach the device to the endoscope.This rendered the autoband device inoperative.The physician replaced the ligator with another device and completed the case.There was no injury or other negative health consequence for the patient.Submission of this report does not, in itself, represent a conclusion that the medical device caused or contributed to an adverse event.

Manufacturer Narrative

The complainant provided a photograph of the device shortly after its withdrawal from the patient, while it was still attached to the endoscope.The photo shows the barrel assembly of the autoband ligator was not fully seated on the distal tip of the endoscope as described in the assembly guide section of the instructions for use.When the barrel assembly of the device is not correctly seated, its capability to withstand lateral force is greatly reduced.

• Brand Name: AUTOBAND LIGATOR
• Type of Device: LIGATOR, ESOPHAGEAL
• Manufacturer (Section D): ENDOCHOICE INC.; 11810 wills rd; alpharetta GA 30009 000
• Manufacturer Contact: 11810 wills rd; alpharetta, GA 30009-0000 ; 6787084743
• MDR Report Key: 4360772
• MDR Text Key: 17266228
• Report Number: 3007591333-2014-00024
• Device Sequence Number: 1
• Product Code: MND
• Combination Product (y/n): N
• Reporter Country Code: GR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2015
• Device Model Number: DBL-293
• Device Catalogue Number: DBL-293
• Device Lot Number: 35382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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