MAUDE Adverse Event Report: UNIMAX MEDICAL SYSTEM 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	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The bag broke while trying to retrieve gallbladder.There were no parts of bag retained in patient.

• Common Device Name: DETACHABLE ENDO POCKET
• Manufacturer (Section D): UNIMAX MEDICAL SYSTEM INC.; 8f-2, no. 127, lane 235; pao chiao rd xindian district; new taipei city, taiwan 231 ; TW 231
• Manufacturer (Section G): UNIMAX MEDICAL SYSTEM 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 rd xindian district; new taipei city, taiwan 231 ; TW 231
• MDR Report Key: 22837442
• Report Number: 3007791595-2025-00004
• Device Sequence Number: 9247379
• Product Code: GCJ
• UDI-Device Identifier: 04714127863504
• UDI-Public: (01)04714127863504(17)300109(10)6252412079
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 08/19/2025

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: 6252412079
• 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: 07/29/2025
• Initial Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (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: 41 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Hispanic