MAUDE Adverse Event Report: ARTHROCARE CORP. PERC DLR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	K7920-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the doctor had an issue placing the cannula.When he removed it to reposition, he noticed there was a "notch" or a "divot" that was perceived to be a crack at first.Either way, the cannula was defective.No patient injury was reported, 30 minutes to 1 hour delay.
Additional Manufacturer Narrative
There was a relationship found between the returned device and the reported incident.Visual inspection under magnification shows a divet in the cannula midway down.Further observation shows that the cannula is slightly bent as well.During removal of the stylus from the cannula, it took a significant amount of force due to the bent cannula.The complaint was verified but the root cause could not be determined with confidence.Several factors could have contributed to the damaged cannula.It is possible that the cannula was damaged in-transit to the customer, the device inadvertently dropped or the device may have been hit against another hard object.There were no indications to suggest the device did not meet product specifications upon release into distribution.Device returned for evaluation.
Event or Problem Description
The procedure was canceled.It was not completed.No patient injuries were reported.

• Brand Name: PERC DLR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7105159
• Report Number: 3006524618-2017-00409
• Device Sequence Number: 11100633
• Product Code: GEI
• UDI-Device Identifier: 00817470004472
• UDI-Public: (01)00817470004472(17)190601(10)2000926
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K030954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other Health Care Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: K7920-01
• Device Catalogue Number: K7920-01
• Device Lot Number: 2000926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2017
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1