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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TENEX HEALTH, INC. TX1 TISSUE REMOVAL SYSTEM - MICROTIP; INSTRUMENT, ULTRASONIC SURGICAL
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TENEX HEALTH, INC. TX1 TISSUE REMOVAL SYSTEM - MICROTIP; INSTRUMENT, ULTRASONIC SURGICAL Back to Search Results
Model Number 554-1003-001
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Pain (1994)
Date of Event 11/01/2020
Type of Reportable Event Serious Injury
Event or Problem Description
A patient reported in a comment on social media (b)(6) that they had more pain in their elbow seven weeks after treatment with a tenex health device than before treatment.The patient also reported that, one week after the elbow procedure with the tenex health device, they had significant shoulder surgery.The cause of the pain is unclear, as is the relationship between the pain and the shoulder surgery.
 
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Brand Name
TX1 TISSUE REMOVAL SYSTEM - MICROTIP
Common Device Name
INSTRUMENT, ULTRASONIC SURGICAL
Manufacturer (Section D)
TENEX HEALTH, INC.
26902 vista terrace
lake forest CA 92630 8123
MDR Report Key11190518
Report Number1000135560-2021-00011
Device Sequence Number11687627
Product Code LFL
UDI-Device Identifier00857156006215
UDI-Public00857156006215
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K123640
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 01/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number554-1003-001
Device Catalogue Number554-1003-001
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/22/2020
Initial Report FDA Received Date01/18/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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