MAUDE Adverse Event Report: TRANSMED (CHINA) CO., LTD. DURACLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number	DC0235W
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Duraclip did not deploy, and the end of it came off after the device was removed from the scope.

• Brand Name: DURACLIP
• Common Device Name: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): TRANSMED (CHINA) CO., LTD.; 2855 broadwalk drive; ann arbor MI 48104
• MDR Report Key: 20673890
• Report Number: 20673890
• Device Sequence Number: 8304889
• Product Code: PKL
• UDI-Device Identifier: 16932619740033
• UDI-Public: (01)16932619740033(17)250228(10)M220301592
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2024
• Report Date (Section F): 10/07/2024

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
• Device Model Number: DC0235W
• Device Catalogue Number: DC0235W
• Device Lot Number: M220301592
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Date Report Sent to FDA: 10/07/2024