MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. ROTH NET PLATINUM - UNIVERSAL; RETRIEVAL DEVICE

Model Number 00715050

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/30/2019

Event Type  malfunction  

Manufacturer Narrative

The user facility reported that the wire loop became partially detached from the drive cable of the device, however the wire loop component remained connected to the device.No component of the device was retained.There have been no other complaints associated with this lot.The instructions for use include the following statements: "closing or retracting the handle too tightly may cause damage to the device's flat wire.Do not exert excessive "bending" pressure on the open (deployed) device; doing so may disfigure either the flat wire and/or the wire frame's shape.The following conditions may not allow the roth net device to function properly: (1) advancing the handle to the open position with too much speed or force, (2) attempting to pass or open the device in an extremely articulated endoscope, (3) attempting to actuate the device in an extremely coiled position and/or (4) actuating the device when the handle is at an acute angle in relation to the sheath.Continuous gentle traction should be applied on the handle to keep the roth net device closed.Excess pressure may cause the net to rupture or tear." the user facility has declined offer of in-service.

Event Description

The user facility reported that the wire loop of a roth net platinum - universal became partially detached during a food bolus procedure.The procedure was completed with another roth net device, and there was no report of injury.

• Brand Name: ROTH NET PLATINUM - UNIVERSAL
• Type of Device: RETRIEVAL DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley rd; mentor, OH 44060 ; 4403586251
• MDR Report Key: 9453211
• MDR Text Key: 197337781
• Report Number: 1528319-2019-00043
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 00816765011973
• UDI-Public: (01)00816765011973
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00715050
• Device Catalogue Number: 00715050
• Device Lot Number: 1706446
• Date Manufacturer Received: 11/11/2019
• 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