MAUDE Adverse Event Report: ENDOCHOICE, INC. RESCUE RAT TOOTH /ALLIGATOR GRASPING FORCEPS; ENDOSCOPIC GRASPING / CUTTING INSTRUMENT

Model Number DGC-383

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/20/2019

Event Type  Injury  

Event Description

After several passes down the scope to retrieve port lodged in esophagus, device couldn't be drawn back through the scope channel.Scope with the device in the channel had to be removed from esophagus and the end of the device cut off to enable device to be removed from scope.On inspection, jaws were twisted / offset, which was why tip of device wouldn't fit back through scope channel.Fda safety report id# (b)(4).

• Brand Name: RESCUE RAT TOOTH /ALLIGATOR GRASPING FORCEPS
• Type of Device: ENDOSCOPIC GRASPING / CUTTING INSTRUMENT
• Manufacturer (Section D): ENDOCHOICE, INC.
• MDR Report Key: 8907146
• MDR Text Key: 154924978
• Report Number: MW5089136
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 008168849010267
• UDI-Public: (01)008168849010267
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2020
• Device Model Number: DGC-383
• Device Lot Number: 180915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 97