MAUDE Adverse Event Report: HANGZHOU, AGS MEDTECH CO, LTD. REPLAY; HEMOSTASIS CLIP, GI

Model Number	1170-02
Medical Device Problem Codes	Mechanical Problem (1384); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a routine colonoscopy, the 16mm hemostasis clip malfunctioned upon deployment, exposing a piece of wire at the end of the deployed clip.The clip deployed and held tissue as intended.The clip was not removed after deployment per the doctor, he felt it was safer to leave the clip and let it pass naturally rather than remove it.There was no patient harm, but the product problem resulted in an exposed wire within the gi tract.

• Brand Name: REPLAY
• Common Device Name: HEMOSTASIS CLIP, GI
• Manufacturer (Section D): HANGZHOU, AGS MEDTECH CO, LTD.; building2,5,7,no.389 xingzhong; linping disctrict; hangzhou, zhejiang 31110 3; CH 311103
• MDR Report Key: 20924614
• Report Number: 2183446-2024-00006
• Device Sequence Number: 17407246
• Product Code: PKL
• UDI-Device Identifier: 00816734021491
• UDI-Public: 00816734021491
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2024
• Report Date (Section F): 12/11/2024

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
• Operator of Device: Health Professional
• Device Model Number: 1170-02
• Device Catalogue Number: 1170-02
• Device Lot Number: 081262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/06/2024
• Device Age: 6 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/06/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/11/2024