MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD. ENDO CLIP II; CLIP, IMPLANTABLE

Model Number 176657

Patient Problem Insufficient Information (4580)

Event Date 07/03/2023

Event Type  malfunction  

Event Description

Endo clip that malfunctioned during laparoscopic cholecystectomy procedure.

• Brand Name: ENDO CLIP II
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 17743943
• MDR Text Key: 323380215
• Report Number: 17743943
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/08/2023,09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 176657
• Device Lot Number: J3E0428NY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2023
• Date Report to Manufacturer: 09/14/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA