MAUDE Adverse Event Report: CONMED CORPORATION DURACLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number	DC0235W
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Attempted to deploy duraclip during egd (esophagogastroduodenoscopy) and clip was jammed and would not deploy.Deployment device removed from patient and scope with clip still attached.
Event or Problem Description
Attempted to deploy duraclip during egd (esophagogastroduodenoscopy) and clip was jammed and would not deploy.Deployment device removed from patient and scope with clip still attached.

• Brand Name: DURACLIP
• Common Device Name: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): CONMED CORPORATION; 525 french rd.; utica NY 13502
• MDR Report Key: 20001526
• Report Number: 20001526
• Device Sequence Number: 14538856
• Product Code: PKL
• UDI-Device Identifier: 16932619740033
• UDI-Public: (01)16932619740033
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024
• Report Date (Section F): 07/22/2024

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: DC0235W
• Device Catalogue Number: DC0235W
• Device Lot Number: M211102594
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 08/23/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Male
• Patient Weight: 98 KG
• Date Report Sent to FDA: 07/22/2024