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

Model Number 00715050

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

The device subject of this event was destroyed and is not available for evaluation.The user facility provided pictures of the detached loop; however, without a returned device, the cause of the reported event could not be determined.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: "continuous gentle traction should be applied on the handle to keep the roth net device closed.The following conditions may cause the device to function improperly: 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 actuating the device when the handle is at an acute angle in relation to the catheter." steris endoscopy has requested that the distributor offer in-service training to the user facility.No further issues have been reported.

Event Description

The distributor reported that the distal loop of a roth net platinum retriever became detached during procedural use to retrieve a polyp in the cecum.The detached portion of the device was retrieved, and the procedure was completed using another device with no reported injury to the patient or user.

• Brand Name: ROTH NET PLATINUM RETRIEVER - UNIVERSAL
• Type of Device: RETRIEVAL DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor, oh
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor, oh
• Manufacturer Contact: coletta cohara ; 5976 heisley rd; mentor, oh
• MDR Report Key: 10317312
• MDR Text Key: 201909325
• Report Number: 1528319-2020-00023
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 00816765011973
• UDI-Public: (01)00816765011973
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/27/2022
• Device Model Number: 00715050
• Device Catalogue Number: 00715050
• Device Lot Number: 1908022
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2019
• 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