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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNB11, GELPOINT PATH WITH ISB, 5.5CM ANOSCOPE AND ACCESSORIES

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APPLIED MEDICAL RESOURCES CNB11, GELPOINT PATH WITH ISB, 5.5CM ANOSCOPE AND ACCESSORIES Back to Search Results
Model Number CNB11
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/21/2019
Event Type  malfunction  
Manufacturer Narrative
The event unit was returned to applied medical for evaluation. Visual inspection of the returned unit confirmed the complainant¿s experience of seal component separation. The shield, an internal plastic component of the seal, had separated from the seal. Based on condition of the unit that was returned, the shield most likely dislodged as a result of non-axial insertion or removal of asymmetrical instrumentation through the sleeve. Applied medical's instructions for use (ifu) states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers. All instruments should be centered axially when inserted through the seal to prevent tearing. " this report is a combined initial and follow-up report.
 
Event Description
Name of procedure being performed: tatme. Detailed description of event: i am reaching out to report a possible product failure in a tatme case at [name] hospital this morning. The product i am reaching out about is ta211 (the gelpoint path w/ l hook) the case began at 8:30 am and ended at 1:00 p. M. The surgeon utilizing the gelpoint path was dr. [name] assisted in the case by dr. [name]. During the case, a small piece of clear plastic appearing to come from a trocar port attached to the gelpoint path came loose and was found in the patient¿s rectum. The surgeon removed the small plastic piece from the port with a grasper. There was no patient harm. Additional information received via email on 25jun2019 from applied medical field assoc: the procedure was a tatme (transanal total mesorectal excision) the device was actually borrowed by [name] hospital from [name] hospital, to have in time for the procedure so that is why you are not finding it. I reached out to my contact[name] for the lot number on the product. She said that their risk management is assessing the situation before she can respond to me, but informed me that there was no patient harm. I will give her a call again tomorrow to get more information. Type of intervention: the surgeon removed the small plastic piece from the port with a grasper. Patient status: there was no harm to the patient.
 
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Brand NameCNB11, GELPOINT PATH WITH ISB, 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 Key9084499
MDR Text Key159194107
Report Number2027111-2019-00592
Device Sequence Number1
Product Code FER
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171701
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCNB11
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/09/2019
Was Device Evaluated by Manufacturer? Yes
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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