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	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - name and address: postal code: (b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
As reported, the lapsac tissue entrapment pouch was removed from the package and could be used without problems.After use, the physician checked inside the package and found two white disc-shaped foreign matter.The case itself was completed without problems.(the foreign matter were not in contact with the patient.) no section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.There were no adverse effects on the patient due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation evaluation: event description as reported, the lapsac tissue entrapment pouch was removed from the package and could be used without problems.After use, the physician checked inside the package and found two white disc-shaped foreign matter.The case itself was completed without problems.(the foreign matter were not in contact with the patient.) no section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.There were no adverse effects on the patient due to this occurrence.Reviews of the complaint history, device history record (dhr), and quality control (qc) procedures were conducted during the investigation.The lapsac tissue entrapment pouch was not returned; therefore, no functional testing or visual inspections could be performed.A document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Review of the device history record, complaint history, quality control documents, and device failure analysis indicates that the device was manufactured out of specification, but does not suggest items in the lot or similar devices in the field or in house are nonconforming.Based upon the available information and results of the investigation, cook has concluded that the mostly likely cause of the reported event was a quality deficiency in the manufacture of the device.Complaint awareness training has been issued for the personnel responsible for the production of the device.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.The failure mode will continue to be trended.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: LAPSAC TISSUE ENTRAPMENT POUCH
• Common Device Name: KGY BAG, INTESTINE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 19809540
• Report Number: 1820334-2024-00995
• Device Sequence Number: 15529510
• Product Code: KGY
• UDI-Device Identifier: 00827002164963
• UDI-Public: (01)00827002164963(17)270216(10)15901183
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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 Model Number: G16496
• Device Catalogue Number: J-LS-080500
• Device Lot Number: 15901183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2024
• 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