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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 Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/25/2018
Event Type  malfunction  
Manufacturer Narrative
 
Event Description
It was reported that during an arcr procedure, when rotator cuff suturing, the tip of jaw could not open. Both handle and needle could not open. Back-up device was used. No patient injury, but 40 minutes delay was reported.
 
Manufacturer Narrative
The returned device, intended for use in treatment, was returned as an mdr 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 open 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 a 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 defined with certainty. Factors unrelated to the design and manufacture of the device which could have contributed to the complaint event are (1) excessive force is be applied to the device when manipulating soft tissue, bone, 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 CORP.
7000 w. william cannon
austin TX 78735
MDR Report Key8081335
MDR Text Key127622274
Report Number3006524618-2018-00603
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 12/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2018
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 Manufacturer11/20/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2018
Is This a Reprocessed and Reused Single-Use Device? No

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