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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES UNKNOWN

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APPLIED MEDICAL RESOURCES UNKNOWN Back to Search Results
Model Number UNKNOWN
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
No product is being returned for evaluation and no lot # has been provided to manufacturer. A final report will be sent once the results have been analyzed.
 
Event Description
Name of procedure being performed: transanal total mesorectal excision with intersphincteric resection. Detailed description of event: please see for a cer that was recently reported to us. All the information we received has been included; however, as the information we received is relatively limited, we're planning to reach out to dr. [name] to gather more information on the event. [name] spoke with dr. [name] at the [name]. He shared feedback on a robotic case using the gelpoint abdominally and gelpoint path transanally. He said that during the case the inner valve of one of the sleeves detached. Additionally, one of the sleeves pushed through the gel and into the patient. Dr. [name] believes these occurrences were caused by the difficulty of the case and maneuvering the robot. He did not confirm which platform this event occurred with (gelpoint or gelpoint path) and did not state whether any material was left in the patient. The units will not be returned. Type of intervention: ni. Patient status: patient injury or illness did not occur. Unknown.
 
Manufacturer Narrative
The event unit was not returned to applied medical for evaluation. As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed. In the absence of the event unit, it is difficult to determine the exact root cause of the event. The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
 
Event Description
Name of procedure being performed: transanal total mesorectal excision with intersphincteric resection. Detailed description of event: please see attached for a cer that was recently reported to us. All the information we received has been included; however, as the information we received is relatively limited, we¿re planning to reach out to dr. [name] to gather more information on the event. [name] spoke with dr. [name] at the [name]. He shared feedback on a robotic case using the gelpoint abdominally and gelpoint path transanally. He said that during the case the inner valve of one of the sleeves detached. Additionally, one of the sleeves pushed through the gel and into the patient. Dr. [name] believes these occurrences were caused by the difficulty of the case and maneuvering the robot. He did not confirm which platform this event occurred with (gelpoint or gelpoint path) and did not state whether any material was left in the patient. The units will not be returned. Type of intervention: ni. Patient status: patient injury or illness did not occur. Unknown.
 
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Brand NameUNKNOWN
Type of DeviceUNKNOWN
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 Key8641619
MDR Text Key149980339
Report Number2027111-2019-00456
Device Sequence Number1
Product Code FER
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/01/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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