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

Catalog Number	SB936
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Bag shredded inside patient's body during procedure.

• 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 rd xindian district; new taipei city, taiwan 231 ; TW 231
• MDR Report Key: 22538875
• Report Number: 3007791595-2025-00002
• Device Sequence Number: 12738575
• Product Code: GCJ
• UDI-Device Identifier: 04714127860763
• UDI-Public: (01)04714127860763(17)29027(10)6252312113
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2025

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
• Device Catalogue Number: SB936
• Device Lot Number: 6252312113
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2024
• 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 Sex: Unknown