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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVATORS ENDO SMARTCAP STERILE WATER BOTTLE ADAPTER

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MEDIVATORS ENDO SMARTCAP STERILE WATER BOTTLE ADAPTER Back to Search Results
Model Number 100145CO2EXT
Device Problems Cap (424); Crack (1135)
Patient Problem Hearing Loss (1882)
Event Date 07/20/2017
Event Type  Injury  
Manufacturer Narrative

Facility reported they have been having issues with their endo smartcaps cracking and popping off their co2 insufflators. In one instance, the smartcap popped off the water bottle and resulted in an audible noise which the doctor in the procedure room complained was very loud. It was reported that this doctor had a hearing test done, thus potential injury is being reported. This is the only facility medivators has received complaints from of this issue. Medivators product specialists and sales representative visited the facility numerous times to investigate this issue and determine the cause of the endo smartcaps cracking. It was observed and noted that the facility recently started using pdi sani-cloth af3 germicidal disposable wipes to wipe down all equipment between procedures to the point that everything is dripping wet. The technicians would pull out approximately an arm's length of wipes and squeeze the liquid onto the carts then wipe it all over everything and allow it to air dry between procedures. Medivators continues to investigate through internal testing of the products and continues to work closely with the facility to resolve this issue. This facility did not disclose the hearing test documentation of the affected physician. This is an isolated, unusual event and there have been no reports of patient harm. Medivators will continue to monitor this complaint and it will be maintained within medivators complaint system.

 
Event Description

A facility reported that the endo smart cap popped off of the reusable water bottle and made a loud noise. It was reported that the doctor at the facility had a hearing test done as a result of the loud noise, thus potential injury is being reported.

 
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Brand NameENDO SMARTCAP
Type of DeviceSTERILE WATER BOTTLE ADAPTER
Manufacturer (Section D)
MEDIVATORS
3150 pollok drive
conroe TX 77303
Manufacturer (Section G)
MEDIVATORS
3150 pollok drive
conroe TX 77303
Manufacturer Contact
alex nelson
14605 28th ave n
minneapolis, MN 55447
7635094799
MDR Report Key6832231
MDR Text Key84073599
Report Number1651395-2017-00001
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK093665
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Remedial Action Inspection
Type of Report Initial
Report Date 08/17/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number100145CO2EXT
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/20/2017
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/30/2017 Patient Sequence Number: 1
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