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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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APPLIED MEDICAL RESOURCES CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number CD004
Device Problem Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/19/2019
Event Type  Malfunction  
Manufacturer Narrative

The event unit is anticipated to return. A follow-up report will be provided upon completion of the investigation. This report is in response to medwatch report #(b)(4).

 
Event Description

Name of procedure being performed "remove a kidney. " detailed description of event: from medwatch uf/importer report #(b)(4) received via mail on march 18th, 2020: the date of the event occurred in (b)(6) 2019. The product is available for return. Event description: "surgeon was using the inzii retrieval system 12/15 mm to take out the kidney. The retrieval bag was inserted into the patient via trocar. When the retrieval system was activated to open and release the bag, it did not do so. Surgeon tried to pull back the handle to reset the device, but it did not work. A new retrieval system was opened and used. " the original intended procedure was "remove a kidney with inzii retrieval system without problems. " the problem that the user had was device malfunction, that is, the device did not do what it was supposed to do. Additional information was received from msn, rn of patient safety & clinical risk. Management at [name], via e-mail on march 30th, 2020: "the information received was from our internal reporting system from the operating room staff that was involved. Surgeon was using the inzii retrieval system 12/15 mm to take out the kidney. The retrieval bag was inserted into the patient via trocar. When the retrieval system was activated to open and release the bag, it did not do so. Surgeon tried to pull back the handle to reset the device, but it did not work. A new retrieval system was opened and used. Since this event happened in (b)(6), therefore it is hard to retrieve any additional information given the new focus of covid-19. " the date of the event was (b)(6) 2019. It is unable to be determined if the bag was not coming out of the shaft/if it was jammed. It is unknown if the bag did not unroll. There was no string/cord breakage. It is unknown if the prongs were exposed. No patient injury or illness occurred associated with the complaint event. As a result of this event, the "retrieval of the system was used and the procedure was completed without complications. " the model/size of the trocar used in the procedure is unknown. Patient status: "retrieval of the system was used and the procedure was completed without complications. " type of intervention "a new retrieval system was opened and used. ".

 
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Brand NameCD004, 12/15MM RETRIEVAL SYSTEM, 5/BX
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
APPLIED MEDICAL RESOURCES
22872 avenida empresa
rancho santa margarita CA 92688
Manufacturer Contact
wendy kobayashi
22872 avenida empresa
rancho santa margarita, CA 92688
9497138059
MDR Report Key9939002
MDR Text Key187082628
Report Number2027111-2020-00450
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK060051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER,USE
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/10/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/08/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCD004
Device Catalogue Number101388201
Device LOT Number1353300
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/18/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/16/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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