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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHROCARE CORP. FIRSTPASS SUTURE PASSER

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ARTHROCARE CORP. FIRSTPASS SUTURE PASSER Back to Search Results
Catalog Number 22-4035
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/15/2019
Event Type  malfunction  
Manufacturer Narrative
Foreign zip code: (b)(6).
 
Event Description
It was reported that during a procedure the device was broken. The pieces were removed, and no delays or injuries were reported, a back-up device was available.
 
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Brand NameFIRSTPASS SUTURE PASSER
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 Key8405233
MDR Text Key138656519
Report Number3006524618-2019-00134
Device Sequence Number1
Product Code HWQ
UDI-Device Identifier00817470000160
UDI-Public00817470000160
Combination Product (y/n)N
Reporter Country CodeUK
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 04/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number22-4035
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2019
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 Unkown

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