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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHROCARE CORP. DISP FIRSTPASS STR PASSR SELF PASSER

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ARTHROCARE CORP. DISP FIRSTPASS STR PASSR SELF PASSER Back to Search Results
Catalog Number 22-4038
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/21/2019
Event Type  malfunction  
Event Description
It was reported that during the surgery the upper jaw got broken, the broken parts were removed from the patient's anatomy. No patient injuries or delay were reported. Back-up device was not available.
 
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Brand NameDISP FIRSTPASS STR PASSR SELF
Type of DevicePASSER
Manufacturer (Section D)
ARTHROCARE CORP.
7000 w. william cannon
austin TX 78735
Manufacturer (Section G)
ARTHROCARE CORP.
7000 w. william cannon
austin TX 78735
Manufacturer Contact
jim gonzales
7000 w william cannon drive
austin, TX 78735
5123585706
MDR Report Key8426480
MDR Text Key139173442
Report Number3006524618-2019-00146
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number22-4038
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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