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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 Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2021
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: tatme case. Hospital: [name}. Gelpoint point path was used for a tatme case. During the case, surgeon tried to remove a grasper from the 10mm sleeve, it also drags out the plastic instrument guide. A 4th piece was introduced. Half way through the surgery, the surgeon tried to remove the grasper again for cleaning but the plastic instrument guide was dragged out again. In the end, circulating nurse had to open another piece of sleeves from [name] (new box). Additional information received via email on 06apr2021 from [name]: patient status: no patient injury. Type of intervention: a new piece was opened.
 
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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 Key11717051
MDR Text Key247287050
Report Number2027111-2021-00464
Device Sequence Number1
Product Code FER
UDI-Device Identifier00607915134440
UDI-Public(01)00607915134440(17)211007(30)01(10)1338891
Combination Product (y/n)N
Reporter Country CodeSN
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 06/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/07/2021
Device Model NumberCNO11
Device Catalogue Number101424301
Device Lot Number1338891
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/08/2018
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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