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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; GYNECOLOGICAL LAPAROSCOPIC KIT

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CARDINAL HEALTH 200, LLC CARDINAL HEALTH; GYNECOLOGICAL LAPAROSCOPIC KIT Back to Search Results
Model Number SMA12LPKGS
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/22/2021
Event Type  malfunction  
Event Description
During set up for a procedure, the surgical tech found a black piece of debris in one of the raytecs from the cardinal custom pack - gyn laparoscopy pack.The entire table was replaced with new supplies.It did not reach the patient.
 
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Brand Name
CARDINAL HEALTH
Type of Device
GYNECOLOGICAL LAPAROSCOPIC KIT
Manufacturer (Section D)
CARDINAL HEALTH 200, LLC
3651 birchwood drive
waukegan IL 60085
MDR Report Key12982979
MDR Text Key282106003
Report Number12982979
Device Sequence Number1
Product Code OHD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/23/2021
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 Operator Other
Device Model NumberSMA12LPKGS
Device Catalogue NumberSMA12LPKGS
Device Lot Number630103
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/23/2021
Event Location Hospital
Date Report to Manufacturer12/13/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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