MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. EXACTO COLD SNARE

Model Number	00711115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices subject of this complaint were returned to steris endoscopy for evaluation.Review of the two devices showed that both handle shafts were significantly bowed inward indicative of the application of excessive force by the user and/or actuation of the device with the handle at an extreme angle in relation to the sheath.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 not allow the device to function properly or cause patient injury: attempting to advance 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/or, attempting to actuate the device when the handle is at an acute angle in relation to the sheath." steris endoscopy offered in-service training to the user facility on the use of the exacto cold snare; however, the facility declined.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch report (b)(4), that during a patient procedure their exacto cold snare handle broke into two pieces.User facility personnel utilized another device, and the patient procedure was completed successfully.No report of injury.

• Brand Name: EXACTO COLD SNARE
• Common Device Name: COLD SNARE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 17663505
• Report Number: 1528319-2023-00035
• Device Sequence Number: 12313907
• Product Code: FGX
• UDI-Device Identifier: 00724995182618
• UDI-Public: 00724995182618
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2023

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 Model Number: 00711115
• Device Catalogue Number: 00711115
• Device Lot Number: 5576287
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown