MAUDE Adverse Event Report: Cook Inc LAPSAC TISSUE ENTRAPMENT POUCH; KGY Bag, Intestine

Model Number	G16496
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2026
Type of Reportable Event	Malfunction

• Brand Name: LAPSAC TISSUE ENTRAPMENT POUCH
• Common Device Name: KGY Bag, Intestine
• Manufacturer (Section D): Cook Inc; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; +1(812)339-2235
• MDR Report Key: 50224960
• Report Number: 1820334-2026-00834
• Device Sequence Number: 21418766
• Product Code: KGY
• UDI-Device Identifier: 00827002164963
• UDI-Public: (01)00827002164963(17)280114(10)16418047
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K910914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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: Other
• Device Model Number: G16496
• Device Catalogue Number: J-LS-080500
• Device Lot Number: 16418047
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2025
• 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: N
• Patient Sequence Number: 1
• Patient Sex: Unknown