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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHROCARE CORPORATION DISP FIRSTPASS STR PASSR SELF PASSER

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ARTHROCARE CORPORATION 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 08/24/2018
Event Type  malfunction  
Event Description
It was reported that while manipulating the handle, when needle come out, the upper jaw broke. Broken piece was removed from patient and procedure was completed with a backup device. No patient injury or delay was reported.
 
Manufacturer Narrative
The returned device, intended for use in treatment, was returned for evaluation. There was a relationship found between the device and the reported incident. Visual inspection shows a device which was returned deployed with an open bracket. One half of the self-capturing is detached and was not returned with the device. There were no manufacturing abnormalities found on the device. During functional evaluation it was tried to activate the instrument. The needle can be deployed by pressing the levers; however the instrument is damaged and cannot be use as intended. The complaint was verified and the cause could not be defined with certainty. Factors that have nothing to do with the design and manufacture of the device and that may have contributed to the complaint event are described: excessive force should not be applied to the device and its levers when manipulating soft tissue, bones or hard objects. 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 CORPORATION
7000 west william cannon drive
austin TX 78735
MDR Report Key7891535
MDR Text Key120973500
Report Number3006524618-2018-00488
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 foreign,health professional,o
Type of Report Initial,Followup
Report Date 11/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number22-4038
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2018
Is This a Reprocessed and Reused Single-Use Device? No

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