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 Consequences Or Impact To Patient (2199)

Event Date 06/19/2019

Event Type  malfunction  

Manufacturer Narrative

The device subject of the reported event was returned to us endoscopy for evaluation.Examination of the device found the that the mesh loop assembly was detached at the connection to the drive cable.Examination also noted damage to the distal catheter and snare loop characteristic of excessive bending prior to deployment of the mesh loop, which contributed to the separation of the mesh loop.The device history record was reviewed and confirmed the device lot was manufactured to specification.There have been no other complaints associated with this lot.The instructions for use include the following statements: "short strokes, 1"-1.5" (2.5cm - 3.8cm) in length, are recommended throughout device passage to avoid sheath kinking." us endoscopy has scheduled in-service training with the user facility regarding proper insertion technique to avoid kinking the device.No additional issues have been reported.

Event Description

The user facility reported that the mesh loop of a roth net platinum retriever detached from the device during a procedure to retrieve gastric polyps.The procedure was completed using a second roth net device, and the detached portion was retrieved.There was no report of 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: 8808260
• MDR Text Key: 151779852
• Report Number: 1528319-2019-00027
• 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: K182909
• 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: 07/19/2019

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 Expiration Date: 03/18/2022
• Device Model Number: 00715050
• Device Catalogue Number: 00715050
• Device Lot Number: 1903302
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2019
• 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