• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CD003, 5MM RETRIEVAL SYSTEM, 10/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

APPLIED MEDICAL RESOURCES CD003, 5MM RETRIEVAL SYSTEM, 10/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number CD003
Device Problem Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/19/2019
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 #5000510000-2020-8008.

 
Event Description

Name of procedure being performed: ni. Detailed description of event: medwatch report received by mail: mw #5000510000-2020-8008 on april 06,2020. Report is for a product problem. Date of event: (b)(6) 2019. Date of report: feb2020. Event occurred in the hospital or. "bag would not deploy. " device available for evaluation. Additional information received via email on 27apr2020 from [name] overlake hospital supply chain manager. This report is for two products of lot number 1333738 that experienced the same issue. No additional information provided about the event other than "bag would not deploy. " the procedure was a robot procedure on (b)(6) 2019. The case was completing but using a new bag. No patient harm or injury. There are no pictures available of the complaint units. The products are available for return. Additional information received via email on 27apr2020 from [name], overlake hospital supply chain manager. Both products malfunctioned during the same case. Patient status: no patient harm or injury. Type of intervention: "new bag was opened. ".

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCD003, 5MM RETRIEVAL SYSTEM, 10/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 Key10016185
MDR Text Key189707136
Report Number2027111-2020-00458
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK100959
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 06/26/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCD003
Device Catalogue Number101072401
Device LOT Number1333738
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/14/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/06/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/09/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-