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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 Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/09/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that during a arthroscopy the firstpass suture passer was not passing or capturing the suture correctly. The procedure was successfully completed without a significant delay it is unknown, if there was a back-up device available. No patient injury or other complications were 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 Key10391939
MDR Text Key202412907
Report Number3006524618-2020-00623
Device Sequence Number1
Product Code HWQ
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 09/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number22-4035
Device Catalogue Number22-4035
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 Received09/16/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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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