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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORPORATION INZII RETRIEVAL SYSTEM LAPAROSCOPE, GENERAL PLASTIC SURGERY

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APPLIED MEDICAL RESOURCES CORPORATION INZII RETRIEVAL SYSTEM LAPAROSCOPE, GENERAL PLASTIC SURGERY Back to Search Results
Model Number CD001
Device Problems Entrapment of Device (1212); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/04/2020
Event Type  Malfunction  
Event Description

While using retrieval bag for gallbladder; bag ripped at seam. Per operative report: preoperative diagnosis: symptomatic cholelithiasis. Postoperative diagnosis: symptomatic cholelithiasis. Procedure performed: laparoscopic cholecystectomy. Gallbladder was placed in [device] and removed from the umbilical trocar site. While doing so, the stone became lodged to the level of fascia and the bag actually separated leaving the stone impacted at the fascial edges. An additional bag was used to place the stone in, and then was subsequently removed without issue. Operative field was examined and noted to be hemostatic.

 
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Brand NameINZII RETRIEVAL SYSTEM
Type of DeviceLAPAROSCOPE, GENERAL PLASTIC SURGERY
Manufacturer (Section D)
APPLIED MEDICAL RESOURCES CORPORATION
22872 avenida empresa
rancho santa margarita CA 92688
MDR Report Key9752971
MDR Text Key180862617
Report Number9752971
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 02/07/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/26/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCD001
Device Catalogue NumberCD001
Device LOT Number1372264
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/07/2020
Event Location Hospital
Date Report TO Manufacturer02/26/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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