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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL INZIL RETRIEVAL SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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APPLIED MEDICAL INZIL RETRIEVAL SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number CD004
Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/13/2015
Event Type  malfunction  
Event Description
During laparoscopic nephrectomy, the surgeon went to use the 15 mm endocatch bag to retrieve kidney mass.First time he used the first bag, the string detached from the instrument on its own, and was hard to retrieve the string in the cavity.The second bag he used, would not close completely, therefore not holding the specimen securely for removal.The specimen fell out of the bag during the retrieval process and made the removal most difficult.Manufacturer response for endo catch, inzil retrieval system (per site reporter).
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Event Description
During laparoscopic nephrectomy, the surgeon went to use the 15 mm endocatch bag to retrieve kidney mass.First time he used the first bag, the string detached from the instrument on its own, and was hard to retrieve the string in the cavity.The second bag he used, would not close completely, therefore not holding the specimen securely for removal.The specimen fell out of the bag during the retrieval process and made the removal most difficult.Manufacturer response for endo catch, inzil retrieval system (per site reporter).
 
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Brand Name
INZIL RETRIEVAL SYSTEM
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
APPLIED MEDICAL
22872 avenida empresa
rancho santa margarita CA 92688
MDR Report Key4705431
MDR Text Key5651906
Report Number4705431
Device Sequence Number1
Product Code GCJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 03/20/2015
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 Physician
Device Catalogue NumberCD004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2015
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/20/2015
Event Location Hospital
Date Report to Manufacturer04/20/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/20/2015
Patient Sequence Number1
Treatment
LAPROSCOPIC SURGERY
Patient Age73 YR
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