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

Model Number 00711170

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2020

Event Type  malfunction  

Manufacturer Narrative

Following receipt of this medwatch steris endoscopy complaint records were reviewed, and no matching event was found based on the given part number, lot number, and date of event; therefore, the user facility is unknown.The device subject of this complaint was not returned to steris endoscopy for evaluation.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.Statements in the instructions for use include: " 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.Actuating the device in an extremely coiled position.Actuating the device when the handle is at an acute angle in relation to the sheath.".

Event Description

Steris endoscopy received an anonymous medwatch report (mw5097835) which reported that a roth net would not fully close during a procedure.The report stated that there was no harm to the patient.

• Brand Name: ROTH NET RETRIEVER - SELECT
• 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: 11133819
• MDR Text Key: 227101549
• Report Number: 1528319-2021-00002
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 00816765013519
• UDI-Public: (01)00816765013519
• Combination Product (y/n): N
• PMA/PMN Number: K182909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2022
• Device Model Number: 00711170
• Device Catalogue Number: 00711170
• Device Lot Number: 1912761
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2019
• 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