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 Foreign Body In Patient (2687)

Event Date 03/22/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to us endoscopy for evaluation.Examination of the device confirmed separation of the distal catheter portion, and found damage to the catheter and drive cable assembly which was not noted in the initial report.Examination of the device has been inconclusive regarding the cause of the catheter separation and source of the additional catheter damage.The device history record was reviewed and confirmed the device was manufactured to specification.There have been no other complaints associated with this lot.A 3-year complaint review found no other instances of catheter detachment.The instructions for use include the following statements: "do not use this device if there is any apparent shipping or handling damage.Short strokes, 1"-1.5" (2.5cm - 3.8cm) in length, are recommended throughout device passage to avoid sheath kinking.The following conditions may not allow the roth net device to function properly: advancing the handle to the open position with too much speed or force, attempting to pass or open the device in an extremely articulated endoscope, attempting to actuate the device in an extremely coiled position and/or actuating the device when the handle is at an acute angle in relation to the sheath." us endoscopy has requested the distributor offer in-service to the user facility including handling prior to use and the user facility has accepted.Date of training is to be determined.No additional issues have been reported.

Event Description

The distributor reported that, during the retrieval of a polyp, a portion of the catheter of a roth net detached on first deployment of the device within the patient.Retrieval of the polyp was completed with a second roth net device and the detached portion of the catheter was retrieved.There was no reported harm to the patient.

• 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: 8592811
• MDR Text Key: 144681918
• Report Number: 1528319-2019-00020
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 00816765011973
• UDI-Public: (01)00816765011973
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K182909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2020
• Device Model Number: 00715050
• Device Catalogue Number: 00715050
• Device Lot Number: 1713142
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2017
• 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