MAUDE Adverse Event Report: UNIMAX MEDICAL SYSTEMS INC.; DETACHABLE ENDO POCKET

Catalog Number	FEP936116
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During procedure when dr.Was attempting to remove the gallbladder in the endo catch bag the bag broke inside of patient.Bag was fully recovered.

• Common Device Name: DETACHABLE ENDO POCKET
• Manufacturer (Section D): UNIMAX MEDICAL SYSTEMS INC.; 8f-2, no. 127, lane 235,; pao chiao rd, xindian district; new taipei city, taiwan 231 ; TW 231
• Manufacturer (Section G): UNIMAX MEDICAL SYSTEMS INC.; 8f-2, no 127, lane 235,; pao chiao rd, xindian district; new taipei city, taiwan 231 ; TW 231
• Manufacturer Contact: kris hsieh ; 8f-2, no.127, lane 235,; pao chiao road, xindian dist.; new taipei city, taiwan 231 ; TW 231
• MDR Report Key: 22324982
• Report Number: 3007791595-2025-00001
• Device Sequence Number: 9023343
• Product Code: GCJ
• UDI-Device Identifier: 04714127863504
• UDI-Public: (01)04714127863504(17)291011(10)6252409145
• Combination Product (Y/N): N
• PMA/510(K) Number: K103510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/17/2025

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 Catalogue Number: FEP936116
• Device Lot Number: 6252409145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 161 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White