MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. ISNARE SYSTEM - OVAL SNARE

Model Number 00711086

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

The device subject of this complaint is not available for return 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: "short strokes, 1"-1.5" (2.5cm - 3.8cm) in length, are recommended throughout device passage to avoid catheter kinking.Before reinserting the device into the endoscope, check to confirm that the needle and snare function and that they are in a retracted position." the distributor has offered in-service training on the use of the isnare system - oval snare to the user facility; however, the facility has not yet responded.No further issues have been reported.

Event Description

The user facility reported that the snare loop of an isnare system - oval snare detached from the device during procedural use.The procedure was completed with another snare and the detached component was retrieved.There was no reported harm to the patient or user of the device.

• Brand Name: ISNARE SYSTEM - OVAL SNARE
• Type of Device: ISNARE
• 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: 11426767
• MDR Text Key: 240043076
• Report Number: 1528319-2021-00007
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 00724995180805
• UDI-Public: (01)00724995180805
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K040961
• 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: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2023
• Device Model Number: 00711086
• Device Catalogue Number: 00711086
• Device Lot Number: 2010896
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• 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