MAUDE Adverse Event Report: COVIDIEN LP ENDO CATCH GOLD; LARYNGOSCOPE, ENDOSCOPE

Model Number	173050G
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During robotic assisted lap chloe an endo cath bag was introduced and malfunctioned- ripped off the deployment device.String stayed attached to bag and was cut from deployment device.

• Brand Name: ENDO CATCH GOLD
• Common Device Name: LARYNGOSCOPE, ENDOSCOPE
• Manufacturer (Section D): COVIDIEN LP; 60 middletown ave; north haven CT 06473
• MDR Report Key: 24078654
• Report Number: 24078654
• Device Sequence Number: 9713342
• Product Code: GCI
• UDI-Device Identifier: 10884523000955
• UDI-Public: (01)10884523000955
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/23/2025
• Report Date (Section F): 12/23/2025

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: 173050G
• Device Lot Number: SUSPECTED - J5F2631MY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2026
• 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 Sex: Female
• Patient Weight: 134 KG
• Date Report Sent to FDA: 12/23/2025