LapSac G16495Recalls & reported problems

Cook Incorporated · LapSac Surgical Tissue Pouch · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002164956), received between Aug 9, 2023 and Aug 9, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Device Contaminated During Manufacture or Shipping1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 9, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
ADDITIONAL INFORMATION RECEIVED ON 09AUG2023: THE PACKAGING MATERIAL WAS INTACT. THE PACKAGE WAS SAID TO BE STORED IN COMPLIANCE WITH STANDARD SPECIFICATIONS. THE STAINS WERE NOTED UPON INSPECTION PRIOR TO USE AND THE DEVICE WAS NOT USED FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17492102 ↗

Device details

UDI-DI	`00827002164956`
Brand	LapSac
Model	G16495
Catalog no.	J-LS-060401
Company	Cook Incorporated
Product code	KGY · BAG, INTESTINE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 12, 2020

Device type (GMDN): Tissue extraction bag

An impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device.

Other BAG, INTESTINE devices

LapSac G16496
Cook Incorporated · BAG, INTESTINE
3 reports

All BAG, INTESTINE devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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