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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 Problems Break (1069); Failure to Advance (2524)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that during a shoulder arthroscopic rotator cuff repair, the device was failing to pass the needle; therefore, the suture through the tissue did not pass properly. The tip of the top jaw was broken, but that was only visible after the disposable part had been removed. The device worked properly, but it was replaced by safety purposes. A backup device was available to complete the procedure successfully. Delay or patient injuries were not reported.
 
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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 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key8490107
MDR Text Key141433937
Report Number3006524618-2019-00171
Device Sequence Number0
Product Code HWQ
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2019
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number22-4035
Device Lot NumberK5001AV
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 Received04/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/24/2017
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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