MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. TALON GRASPING DEVICE

Model Number 00711175

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Date 07/02/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, a complaint was received concerning trauma to tissue which occurred during use of the talon grasping device for removal of an esophageal meat impaction.During procedure, the physician observed a red area with slight bleeding, discontinued use of the talon, and completed the procedure with a similar pronged grasping device.After removal of the food bolus, a sub centimeter mucosal tear was detected.A chest x-ray was negative for pneumothorax or pneumomediastinum, indicating no perforation and no free air.An esophagram detected mucosal abnormality without evidence of extravasation.The affected tissue was described as an area similar to a small mucosal biopsy site after a specimen was taken, 2mm in depth, but not extending into the mediastinum.The pt was admitted for overnight observation and was discharged the next day.The underlying pt condition is unk.The pt returned for a f/u examination on (b)(6) 2014 and no new info concerning the pt condition was provided.

Manufacturer Narrative

The facility was new to the device, reporting only one prior use.The device configuration includes a handle assembly, insertion catheter, internal control cable, and a wire form grasping component with four atraumatic distal tips.The product was not returned and the lot number was not known, consequently there was no examination of the product or review of the manufacturing record.This report will be updated if add'l info becomes available.

• Brand Name: TALON GRASPING DEVICE
• Type of Device: GRASPING DEVICE
• Manufacturer (Section D): 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: 3999234
• MDR Text Key: 4689663
• Report Number: 1528319-2014-00012
• Device Sequence Number: 1
• Product Code: FGO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00711175
• Device Catalogue Number: 00711175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2014
• Initial Date FDA Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization