MAUDE Adverse Event Report: ARTHROCARE CORP. SABER 30 DEGREE ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	AC4330-01
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during surgery, after using the saber wand, a burning smell was perceived from it.The connection was checked and it was evident that the console connector was black.It was not reported if there were any delays in a surgical procedure.The procedure was successfully completed with the help of an electro scalpel.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3,h6: the device, used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned for evaluation.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found no related failures; this failure mode will be trended to assess for any necessary corrective actions visual inspection could not be conducted as no device was returned.Functional evaluation could not be conducted as no device was returned.Potential factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: 1.The device may have not been fully plugged into the concomitant controller, thus resulting in a short of the cable connector.2.An issue with one of the concomitant devices in use at the time of this complaint event.There are no indications to suggest the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
H10.Additional information in b5.
Event or Problem Description
It was reported that during a knee arthroscopy, after using the saber wand, a burning smell was perceived from it.The connection was checked and it was evident that the console connector was black.The procedure was successfully completed without delay with the help of an electro-scalpel.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6 h10: the device, used in treatment, was returned for evaluation.There was a relationship between the complaint and the device.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions visual inspection of the device revealed minimal electrode erosion - no abnormalities were observed the wand was connected to a compatible controller and was activated in a beaker of saline solution for a few moments in which the controller exhibited an e-4 error.A continuity test was conducted from the connector block to the tip of the wand and revealed a short with the return.The handle was opened and there were no discrepancies observed with the active and return wires inside the handle.A continuity test was then conducted from the cut cable near the handle to the tip of the device and did not reveal a short; therefore, the exact location of the failure was not conclusive.The complaint has been verified and the root cause was determined to be an electrical component failure.Factors, which may have contributed to the reported complaint include: 1) the device coming into contact with another metallic object, or using the device as a lever to enlarge the surgical site.2) a minute trace of saline breaking the barrier between the cap and spacer will cause the controller to generate an e-4 error -- the output is deactivated in order to protect the wand and generator from excessive power delivery.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SABER 30 DEGREE ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9919234
• Report Number: 3006524618-2020-00143
• Device Sequence Number: 19615859
• Product Code: GEI
• UDI-Device Identifier: 00817470004854
• UDI-Public: 00817470004854
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/11/2020

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: Health Professional
• Device Expiration Date: 04/07/2021
• Device Model Number: AC4330-01
• Device Catalogue Number: AC4330-01
• Device Lot Number: 2013219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 04/01/2020; 04/27/2020; 08/10/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 04/07/2020; 05/04/2020; 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Weight: 85