MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. SHORT THROW SNARE - MINI-OVAL

Model Number	00711018
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The short throw snare is an electrosurgical device designed to be used endoscopically to grasp, dissect and transect tissue during gastrointestinal (gi) endoscopic procedures.These devices are used with diathermic energy.The reported use of the device for foreign body retrieval is not within the intended use of this product.The device history record was reviewed and confirmed the devices were manufactured to specification.There have been no other complaints associated with this lot.The device subject of this event was returned to us endoscopy for evaluation.Examination of the device found one end of the snare loop wire had separated from the cable assembly and the other end of the loop remained attached to the cable assembly.The snare loop wire was deformed indicating excessive force during use.Us endoscopy has requested the distributor offer in-service training to the user facility on the intended use of the device.
Event or Problem Description
The distributor in the (b)(4) reported snare loop became partially detached during a procedure to retrieve a feeding tube bumper.A second snare was used to complete the procedure.There was no report of harm to the patient or user.

• Brand Name: SHORT THROW SNARE - MINI-OVAL
• Common Device Name: SNARE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 7836649
• Report Number: 1528319-2018-00028
• Device Sequence Number: 1980864
• Product Code: FDI
• UDI-Device Identifier: 00816765010839
• UDI-Public: (01)00816765010839
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K924105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/30/2021
• Device Model Number: 00711018
• Device Catalogue Number: 00711018
• Device Lot Number: 1801694
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1