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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 Break (1069); Device Fell (4014)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/21/2018
Event Type  malfunction  
Event Description
It was reported that when passed suture through the cuff, as he pulled the passer out, one of the self capture jaws fell off in the patient. Pieces were removed from patient. A backup device was available to complete the procedure with no delay or patient injuries.
 
Manufacturer Narrative
The reported disposable firstpass suture passer, intended for use in treatment, was returned for evaluation. A relationship between the device and reported incident was established based on our visual observations. From the information provided, ¿one of the self-capture jaws fell off in the patient. ¿ visual evaluation shows one half of the self-capturing is detached and was not returned with the device. No other visual discrepancies. During functional evaluation the two step trigger performed as intended. The needle could be deployed by pressing the levers; however the instrument is damaged and cannot be use as intended. Based on visual observations, customer¿s complaint was confirmed. An exact root cause cannot be determined with confidence; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: excessive force. Incorrect suture used during the case. Insufficient retention of suture capture. Excessive force applied to the product or incorrect clinical suture used can result in product failure or damage to the product. There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
 
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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 w. william canon drive
austin, TX 78735
5123585706
MDR Report Key7928424
MDR Text Key122645925
Report Number3006524618-2018-00518
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number22-4038
Device Lot Number2016281
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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