MAUDE Adverse Event Report: HANGZHOU AGS MEDTECH CO., LTD. REPLAY; HEMOSTATIC CLIP FOR THE GI TRACT

Model Number	1170-02
Medical Device Problem Codes	Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
Date of Event	10/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had a colonoscopy on 10-27-2023.One 13mm polyp was removed in the cecum and the resected area was clipped.One 12mm polyp was removed in the mid-ascending colon and that resected area was also clipped.The clips deployed properly and the examination was normal on direct and retroflexion views.On (b)(6) 2023, the patient returned to the er with bleeding.On (b)(6) 2023, the patient was re-scoped.That examination reported that both clips had been dislodged.New clips were placed in both areas and no further intervention was necessary.

• Brand Name: REPLAY
• Common Device Name: HEMOSTATIC CLIP FOR THE GI TRACT
• Manufacturer (Section D): HANGZHOU AGS MEDTECH CO., LTD.; building 6, kangxin rd no 597; qianjiang economic dev area; hangzhou, zhejiang 31110 6; CH 311106
• MDR Report Key: 18191323
• Report Number: 2183446-2023-00005
• Device Sequence Number: 20651871
• Product Code: PKL
• UDI-Device Identifier: 00816734021491
• UDI-Public: 00816734021491
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/21/2023
• Report Date (Section F): 11/21/2023

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 Expiration Date: 05/17/2026
• Device Model Number: 1170-02
• Device Catalogue Number: 1170-02
• Device Lot Number: 068150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/02/2023
• Device Age: 6 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 11/11/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/21/2023