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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
Model Number 22-4038
Device Problem Insufficient Information (3190)
Patient Problem Injury (2348)
Event Date 02/19/2020
Event Type  Injury  
Event Description
It was reported that, during a shoulder arthroscopy, when the firstpass suture passer was fired, the product locked inside of the joint. After finally getting product out of joint it was noticed that the jaw was stuck in closed position and the needle was bent out of the side of the jaw, instead of firing up through the self-capture mechanism. A replacement product was on hand. It is unknown if surgery was delayed as consequence of the allegation. There was a slight damage to the patient tissue. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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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 Key9875474
MDR Text Key187909727
Report Number3006524618-2020-00122
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
Report Date 06/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number22-4038
Device Catalogue Number22-4038
Device Lot Number2042053
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/08/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/24/2020 Patient Sequence Number: 1
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