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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
Model Number 22-4035
Device Problems Break (1069); Material Separation (1562)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/15/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that, during an arthroscopy, when the firstpass was twisted it broke. There was a backup device available. No delay or patient injury was reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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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
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10818578
MDR Text Key215977233
Report Number3006524618-2020-00974
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeBR
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 12/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number22-4035
Device Catalogue Number22-4035
Device Lot NumberK5001BB
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 Received12/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/20/2017
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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