MAUDE Adverse Event Report: YANGZHOU FARTLEY MEDICAL CO LTD HEMOSTASIS CLIP 16MM 2300MM LENGTH; HEMOCLIP ROTATABLE

Model Number	SCA-23-230-16
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	06/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the hemostasis clip tip of the device fell off during a diagnostic procedure, resulting in excessive bleeding.The tip was recovered and the procedure was completed with the same device.Follow-up attempts have been made to gather further information, but no response has been received from the customer.

• Brand Name: HEMOSTASIS CLIP 16MM 2300MM LENGTH
• Common Device Name: HEMOCLIP ROTATABLE
• Manufacturer (Section D): YANGZHOU FARTLEY MEDICAL CO LTD; no.5 beizhou road, lidian town; guangling, yangzhou, jiangsu 22510 6; CH 225106
• MDR Report Key: 22501986
• Report Number: 2429304-2025-00207
• Device Sequence Number: 15567986
• Product Code: PKL
• UDI-Device Identifier: 06936603218228
• UDI-Public: 06936603218228
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2025
• Report Date (Section F): 07/14/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: SCA-23-230-16
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/16/2025
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/14/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/14/2025