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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNO11, GELPOINT PATH, 5.5CM ANOSCOPE AND ACCESSORIES

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APPLIED MEDICAL RESOURCES CNO11, GELPOINT PATH, 5.5CM ANOSCOPE AND ACCESSORIES Back to Search Results
Model Number CNO11
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 04/26/2019
Event Type  malfunction  
Manufacturer Narrative
The event unit returned for evaluation. A follow-up report will be provided upon completion of investigation.
 
Event Description
Name of procedure being performed: na (incoming inspection). Detailed description of event: the product did not pass the incoming inspection of po#19-02app because of torn packaging. Details are shown on the attached file. Type of intervention: na. Patient status: no patient involved.
 
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Brand NameCNO11, GELPOINT PATH, 5.5CM
Type of DeviceANOSCOPE AND ACCESSORIES
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 Key8834213
MDR Text Key177978606
Report Number2027111-2019-00532
Device Sequence Number1
Product Code FER
UDI-Device Identifier00607915134440
UDI-Public(01)00607915134440(17)211029(30)01(10)1338892
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K171701
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/29/2021
Device Model NumberCNO11
Device Catalogue Number101424301
Device Lot Number1338892
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/30/2018
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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