MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD 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.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report has been submitted by the importer under this mdr report number (b)(4).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The subject device was investigated by the parts supplier and not returned to olympus for evaluation, and limited information was provided by the supplier¿s conclusion.Therefore, based on the results of the investigation, the cause of the detachment is considered not to be related to a manufacturing fault of the device.This supplemental report includes a correction to a2, a3, a4, and b7 to provide information that was inadvertently not included in the initial medwatch.Also, an update has been made to d9 and h3 olympus will continue to monitor field performance for this device.

• Brand Name: ARV120 ENDOCUFF-V L GREEN PK8
• Common Device Name: ENDOCUFF VISION
• Manufacturer (Section D): KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD; keymed house, stock road; southend on sea, essex SS25Q H; UK SS25QH
• Manufacturer (Section G): KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD; keymed house, stock road; southend on sea, essex
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19142836
• Report Number: 9611174-2024-00023
• Device Sequence Number: 20684246
• Product Code: FED
• UDI-Device Identifier: 15019778008660
• UDI-Public: 15019778008660
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K162205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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?: No
• Date Returned to Manufacturer: 03/29/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 88 KG