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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 Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event Description
It was reported that during an unknown surgery, the firstpass broke. It is unknown whether the event happened internal or external to the patient. It is unknown if a back-up device was available and if a delay occurred. No other complications were reported.
 
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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
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key12441423
MDR Text Key270541898
Report Number3006524618-2021-00897
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number22-4038
Device Lot Number2070220
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/17/2021
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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