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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORPORATION KII OPTICAL 8 MM X 100 MM TROCAR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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APPLIED MEDICAL RESOURCES CORPORATION KII OPTICAL 8 MM X 100 MM TROCAR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number C0Q19
Device Problem Material Puncture/Hole (1504)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/06/2023
Event Type  malfunction  
Event Description
During a robotic laparoscopic removal of fibroids, a clear cone shaped piece of plastic was found floating in patient's abdomen.Upon inspection all trocars being used in procedure appeared to be whole.No pieces missing.Plastic piece was removed from abdomen and placed in specimen cup.Private scrub stated she believed it may have been an internal flange from one of the 8 mm pink ports being used.8 mm ports were bagged at end of case put aside.(disassembled one to verify.) unfortunately, the team did not save any of the packaging for this device, so we cannot verify the lot number.Possible lot #: 1472552 or 1473089.Packaging not saved, we have 2 different lot numbers on our shelf.
 
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Brand Name
KII OPTICAL 8 MM X 100 MM TROCAR
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
APPLIED MEDICAL RESOURCES CORPORATION
22872 avenida empresa
rancho santa margarita CA 92688
MDR Report Key16627497
MDR Text Key312142279
Report Number16627497
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberC0Q19
Device Catalogue NumberC0Q19
Device Lot NumberPOSSIBLE 1472552 OR 1473089
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/16/2023
Event Location Hospital
Date Report to Manufacturer03/28/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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