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

Catalog Number	AC4330-01
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the radio frequency saber 30 was passed in order to release tissue through the cannula, but this presents resistance and when we were trying to introduce it a fracture sound was heard, it was verified and it was evident that the hook of the radiofrequency did not come out.The respective search was made inside the cannula and the patient, but it was not found.The pieces was left inside the patient in a place where is no danger.
Additional Manufacturer Narrative
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.Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
The reported device, used in treatment, was not returned for evaluation.A relationship, if any, between the reported device and the reported event could not be determined since the reported product was not returned for evaluation.The device reported in the complaint was not returned for evaluation.A device still in the inner tray with seals intact was returned; therefore, visual inspection and functional testing of the reported damaged device could not be performed.There were no manufacturing abnormalities observed with the device that was returned.The complaint could not be verified, nor could a root cause be determined with confidence.If the reported damaged product associated with this event is returned at a future date, this evaluation will be reopened for investigation.Factors not associated with the manufacture or design of the device which could result in damage to the tip could be improper insertion or removal from an apparatus, excessive force applied to the tip, using the wand as a lever to enlarge the surgical site or gain access to tissue, or come into abrupt contact with a hard (metallic) object.These factors can lead to unintended detachment and are outlined in the precautionary statements in the instruction for use.There were no indications during manufacturing record review 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: 8425845
• Report Number: 3006524618-2019-00144
• Device Sequence Number: 1062306
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2019

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: 10/24/2020
• Device Catalogue Number: AC4330-01
• Device Lot Number: 2007522
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2019
• Supplement Date Received by Manufacturer: 04/18/2019; 08/12/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 04/22/2019; 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 86