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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
Catalog Number 22-4038
Device Problems Misfire (2532); Physical Resistance/Sticking (4012)
Patient Problem No Code Available (3191)
Event Date 03/20/2019
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that, during a shoulder arthroscopy, the firstpass suture passer needle fired outside the jaw instead of through the suture capture; both the needle and the jaw got stuck in the locked position, with the tendon in between. As a result of the incident, it had to be used a gold awl to open up the jaw of the passer. The tendon was frayed after its release. A back-up device was available to complete the procedure. Neither surgical delay nor patient injuries were stated.
 
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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
jim gonzales
7000 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key8491544
MDR Text Key141200070
Report Number3006524618-2019-00172
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
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 06/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/11/2021
Device Catalogue Number22-4038
Device Lot Number2023577
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/11/2018
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: 04/08/2019 Patient Sequence Number: 1
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