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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 Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/26/2018
Event Type  malfunction  
Event Description
It was reported that during the procedure, the tip of the needle was broken. No patient injuries nor delay were reported. Backup was available to complete the procedure.
 
Manufacturer Narrative
The returned device, intended for use in treatment, was returned for evaluation. There was no relationship found between the device and the reported incident. Visual inspection shows a device which was returned deployed. The instrument was returned with an opened bracket. There were no manufacturing abnormalities found on the device. During functional evaluation the two step trigger performed as intended. The bracket could be closed/opened as specified. The needle deploy through an om-3003 dome foam model by using the index finger and depressing the trigger. The self-capture is working as intended and the ultratape (cobraid blue 38¿) was successfully passed through as intended. The complaint was not verified and the root cause could not be determined with certainty. 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
MDR Report Key8065914
MDR Text Key127213309
Report Number3006524618-2018-00593
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
Type of Report Initial,Followup
Report Date 12/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number22-4038
Device Lot Number2016279
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2018
Is This a Reprocessed and Reused Single-Use Device? No

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