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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNB10, GELPOINT PATH WITH ISB, 4CM ANOSCOPE AND ACCESSORIES

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APPLIED MEDICAL RESOURCES CNB10, GELPOINT PATH WITH ISB, 4CM ANOSCOPE AND ACCESSORIES Back to Search Results
Model Number CNB10
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/02/2020
Event Type  malfunction  
Manufacturer Narrative
The event unit returned to applied medical for evaluation. A follow-up report will be provided upon completion of the investigation.
 
Event Description
Name of procedure being performed: teo. Detailed description of event: hospital: [name] hospital. The inner valve of the access channel fell out before inserting the gelpoint path into the patient's rectum. Used another access channel as replacement. Patient status: no patient injury. Type of intervention used another access channel as replacement.
 
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Brand NameCNB10, GELPOINT PATH WITH ISB, 4CM
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 Key10368355
MDR Text Key201775581
Report Number2027111-2020-00523
Device Sequence Number1
Product Code FER
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K171701
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCNB10
Device Catalogue Number101472124
Device Lot Number1372651
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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