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

Catalog Number	SB1079
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the strings broke on the bag.They believe the prongs on the bag caused a bowel injury resulting in a sigmoid colectomy.

• Common Device Name: DETACHABLE ENDO POCKET
• Manufacturer (Section D): UNIMAX MEDICAL SYSTEMS INC.; 8f-2, no.127, lane 235,; pao chiao rd, xindian dist.; new taipei city, taiwan TW 23 1; TW TW 231
• Manufacturer (Section G): UNIMAX MEDICAL SYSTEMS INC.; 8f-2, no.127, lane 235,; pao chiao road, xindian dist.; new taipei city, 231 ; TW 231
• Manufacturer Contact: kris hsieh ; 8f-2, no.127, lane 235,; pao chiao road, xindian dist.; new taipei city, 231 ; TW 231
• MDR Report Key: 23787375
• Report Number: 3007791595-2025-00013
• Device Sequence Number: 5712198
• Product Code: GCJ
• UDI-Device Identifier: 04714127860688
• UDI-Public: 04714127860688
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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: SB1079
• Device Lot Number: 6252507133
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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