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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCLARENT, INC. TDP0005 EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

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ACCLARENT, INC. TDP0005 EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
Model Number TDP0005
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/19/2020
Event Type  malfunction  
Manufacturer Narrative
Manufacturer¿s ref. No: (b)(4). Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided. The device lot number is not available / not reported. The expiration date of the device is not known. The initial reporter email was not reported / available. The device is available to be returned for evaluation and testing. However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation. If the device returns, a device investigation will be performed. The device manufacture date is not known as the device lot number is not available / not reported. Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission. The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report. Additional information will be submitted within 30 days of receipt.
 
Event Description
The healthcare professional reported that during an in-office primary balloon sinuplasty procedure, the trudi probe (tdp0005 / lot#: unknown) for the trudi nav system broke; this occurred while using the bending tool. There was no difficulty in removing the probe from the patient¿s body. The broken probe was replaced, and the procedure was resumed to completion. There was no report of any patient adverse event or complication.
 
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Brand NameTDP0005
Type of DeviceEAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
ACCLARENT, INC.
31 technology drive
irvine CA 92618
Manufacturer (Section G)
ACCLARENT, INC.
31 technology drive
irvine CA 92618
Manufacturer Contact
gabriel alfageme
31 technology drive
irvine, CA 92618
949789-868
MDR Report Key10805062
MDR Text Key217160554
Report Number3005172759-2020-00007
Device Sequence Number1
Product Code PGW
UDI-Device Identifier10705031464193
UDI-Public10705031464193
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193453
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 10/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTDP0005
Device Catalogue NumberTDP0005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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