MAUDE Adverse Event Report: KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) ARV120 ENDOCUFF-V L GREEN PK8; ENDOCUFF VISION

Model Number	K10037617
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, during the colonoscopy screening, the arv120 endocuff fell off a scope into the patient's sigmoid colon.The endocuff was successfully removed with forceps.A procedural delay occurred but not more than 30 minutes and the patient was not under anesthesia.The outcome of the procedure was not affected as a result of the issue and there was no unplanned diagnostic imaging needed to locate the device and confirm it was removed.The procedure was not completed successfully due to poor colonoscopy prep.The method used to attached the endocuff was by pushing it on to the end of the scope.The device was inspected before use and did not appear broken, cracked, or damaged.

• Brand Name: ARV120 ENDOCUFF-V L GREEN PK8
• Common Device Name: ENDOCUFF VISION
• Manufacturer (Section D): KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT); keymed house, stock road; southend-on-sea, essex SS25Q H; UK SS25QH
• MDR Report Key: 19142822
• Report Number: 2429304-2024-00228
• Device Sequence Number: 7477767
• Product Code: FED
• UDI-Device Identifier: 15019778008660
• UDI-Public: 15019778008660
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2024
• Report Date (Section F): 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: K10037617
• Device Lot Number: 079161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2024
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/25/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown