MAUDE Adverse Event Report: ENDOCHOICE INC. BOA POLYPECTOMY SNARE; EC SINGLE USE, POLYPECTOMY SNARE

Catalog Number DSO-013

Device Problems Loss of or Failure to Bond (1068); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

The device lot was evaluated by the manufacturer and it was determined that the cause of the snare handle break was due to a lack of adherence between materials intended to be joined together by an adhesive, causing the ring slider to dissociate from the handle.This device lot was quarantined and reinspected for this malfunction.

Event Description

It was reported by a user facility that the snare ring slider separated from the handle during a case.There was no report of injury or other negative health consequence to any patient, as this occurred prior to the case.

• Brand Name: BOA POLYPECTOMY SNARE
• Type of Device: EC SINGLE USE, POLYPECTOMY SNARE
• Manufacturer (Section D): ENDOCHOICE INC.; 11810 wills rd; alpharetta GA 30009
• Manufacturer Contact: daniel hoefer ; 11810 wills rd; alpharetta, GA 30009 ; 6787084743
• MDR Report Key: 5305606
• MDR Text Key: 33904544
• Report Number: 3007591333-2015-00083
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Not Applicable
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2020
• Device Catalogue Number: DSO-013
• Device Lot Number: 150812301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• 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