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Model Number IV X
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
This mdr is submitted in response to ae report #mw5095572 published on maude. Based on the limited information included in the anonymous report and our internal review of all customer call data, the reported event could not be confirmed. Without additional details about the patients, evidence about the incidents, information about product at issue, or contact information for follow up, monarch lacks necessary information to determine the root cause of the reported patient harms.
Event Description
During routine review of the maude database, monarch became aware of ae report #mw5095572, an anonymous report containing allegations of serious harm (hypoglycemia) to three patients & one patient death. However, the report contained very little detail about facts or circumstances leading to the alleged harms/death, which endotool product(s) is involved, how the product(s) was used, or any information useful in verifying the customer or facts. The report source states "i have reported all three patients to our quality assurance team. I spoke with the clinical team of the pharmacy and spoke with the head of the icu. Sadly there have been no changes that would prevent another patient from being harmed. " although user facilities are required by law to report device-related serious injuries and deaths to the manufacturer, monarch's internal investigation did not discover any reports of patient harm or death that corresponds with this report. Using the limited information available in the report, monarch queried all customer call records to find all records that could be related to this adverse event, conducted a thorough review of any potentially related cases and contacted customers for additional information, as needed; however, no evidence of malfunction resulting in patient harms/death was discovered. Without further information about the circumstances leading to the alleged harms/death or the events themselves we cannot conclude that any endotool software caused or contributed to the reported adverse events. A supplemental report will be filed if additional information becomes available.
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Type of DeviceENDOTOOL IV
Manufacturer (Section D)
4400 stuart andrew blvd.
suite n
charlotte, nc
Manufacturer Contact
brian johnson
4400 stuart andrew blvd.
suite n.
charlotte, nc 
MDR Report Key10513948
MDR Text Key206341487
Report Number3009864844-2020-90003
Device Sequence Number1
Product Code NDC
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 07/17/2020,09/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberIV X
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/17/2020
Distributor Facility Aware Date08/12/2020
Event Location Hospital
Date Manufacturer Received08/12/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/10/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/10/2020 Patient Sequence Number: 1