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

Model Number 00711018

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Shock (2072); Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

Us endoscopy requested additional information concerning the report of shock, however the user facility would not disclose additional details.The device subject of the reported event was not returned for evaluation.Us endoscopy is unable to determine whether the snare contributed to the reported event.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: "position patient return electrode and connect to electrosurgical unit following instructions from the electrosurgical unit manufacturer.Consult the electrosurgical generator manufacturer's instructions for use for proper settings and use of the electrical surgical generator." us endoscopy has requested that the distributor offer in-service training to the user facility.No additional issues have been reported.

Event Description

The distributor reported that during a patient procedure, while using a short throw snare for a polypectomy the patient flinched and experienced discomfort described as "shock".The user facility repositioned the grounding pads, checked the electrosurgical generator settings, replaced the snare with a second short throw snare and completed the procedure.There were no injuries associated with the user or patient.No medical treatment was sought or administered.

• Brand Name: SHORT THROW - SNARE - MINI-OVAL
• Type of Device: POLYPECTOMY SNARE
• 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: 8941530
• MDR Text Key: 155965781
• Report Number: 1528319-2019-00032
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 00816765010839
• UDI-Public: (01)00816765010839
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K924105
• 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: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2021
• Device Model Number: 00711018
• Device Catalogue Number: 00711018
• Device Lot Number: 1820082
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2018
• 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