MAUDE Adverse Event Report: MONARCH MEDICAL TECHNOLOGIES ENDOTOOL IV

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.

• Brand Name: ENDOTOOL IV
• Type of Device: ENDOTOOL IV
• Manufacturer (Section D): MONARCH MEDICAL TECHNOLOGIES; 4400 stuart andrew blvd.; suite n; charlotte, nc
• Manufacturer Contact: brian johnson ; 4400 stuart andrew blvd.; suite n.; charlotte, nc ; 5249660
• MDR Report Key: 10513948
• MDR Text Key: 206341487
• Report Number: 3009864844-2020-90003
• Device Sequence Number: 1
• Product Code: NDC
• Combination Product (y/n): N
• PMA/PMN Number: K053137
• Number of Events Reported: 1
• 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 Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IV X
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2020
• Distributor Facility Aware Date: 08/12/2020
• Event Location: Hospital
• Date Manufacturer Received: 08/12/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/10/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other