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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHROCARE CORP. DISPOSABLE FIRSTPASS SUTURE PASSER, SELF
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ARTHROCARE CORP. DISPOSABLE FIRSTPASS SUTURE PASSER, SELF Back to Search Results
Catalog Number 22-4038
Device Problems Mechanical Jam (2983); Ejection Problem (4009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/04/2020
Event Type  Injury  
Event Description
It was reported that the shoulder rotator cuff procedure, the jaw of the firstpass could not be opened and the trigger was abnormal. The procedure was completed by using a epidural needle and no significant delay 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 NameDISPOSABLE FIRSTPASS SUTURE PASSER, 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 Key10190101
MDR Text Key196267625
Report Number3006524618-2020-00416
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeJA
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 10/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number22-4038
Device Lot Number2046631
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/12/2019
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: 06/24/2020 Patient Sequence Number: 1
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