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	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
While removing contained specimen in specimen pouch, through the umbilicus, the specimen pouch ripped from the bottom.Dr.[redacted] retrieved all contents of compromised pouch three other endo catch devices from same lot pulled from shelf.

• 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: 23476057
• Report Number: 23476057
• Device Sequence Number: 10329939
• Product Code: GCI
• UDI-Device Identifier: 20884523000952
• UDI-Public: (01)20884523000952
• 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): 10/15/2025
• Report Date (Section F): 10/15/2025

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: J5F2474MY
• 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: 11/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2025
• 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 Age: 52 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Date Report Sent to FDA: 10/15/2025