MAUDE Adverse Event Report: PT. CIBA VISION Batam CENTURION Surgical Procedure Pak; General surgery tray (kit)

Catalog Number	8065752200
Medical Device Problem Codes	Suction Problem (2170); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2026
Type of Reportable Event	Malfunction

• Brand Name: CENTURION Surgical Procedure Pak
• Common Device Name: General surgery tray (kit)
• Manufacturer (Section D): PT. CIBA VISION Batam; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• Manufacturer (Section G): PT. CIBA VISION Batam; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; +1(800)757-9780
• MDR Report Key: 50235077
• Report Number: 9681121-2026-00235
• Device Sequence Number: 10261792
• Product Code: LRO
• UDI-Device Identifier: 00380657522002
• UDI-Public: (01)00380657522002(17)280301(11)260306(10)31621681
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

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: 8065752200
• Device Lot Number: 31621681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 08/13/2026
• Date Device Manufactured: 03/06/2026
• 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