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

Model Number 00711175

Device Problem Detachment Of Device Component (1104)

Patient Problem Laceration(s) of Esophagus (2398)

Event Type  Injury  

Event Description

A complaint was received regarding the talon grasping device.The talon grasping device is intended for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract.The user reported that during removal of a food impaction, a wire component found on the distal grasping assembly became detached.The talon grasping device was removed from the endoscope, and a snare device was used to retrieve the wire component.The remaining food impaction was pushed out of the esophagus and lacerations with embedded food were found in the esophageal tissue.The esophagus was assessed for perforation no treatment was required.

Manufacturer Narrative

A complaint was received regarding the talon grasping device.The talon grasping device is intended for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract.The user reported during removal of a food impaction, a wire component found on the distal grasping assembly became detached.The talon grasping device was removed from the endoscope, and a snare device was used to retrieve the wire component.The remaining impaction was pushed out of the esophagus and lacerations with embedded food were found in the esophageal tissue.The esophagus was assessed for perforation; no treatment was required.Investigation of this event is currently in process.A follow up report will be submitted when 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 oleska ; 5976 heisley rd.; mentor, OH 44060 ; 4403586263
• MDR Report Key: 4600119
• MDR Text Key: 5470329
• Report Number: 1528319-2015-00009
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: 00711175
• Device Catalogue Number: 00711175
• Device Lot Number: 1407418
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention