MAUDE Adverse Event Report: ARTHROCARE CORP. AMBIENT HIPVAC 50 IFS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number ASHA4730-01

Device Problems Break (1069); Detachment Of Device Component (1104); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Defective Component (2292); Component Missing (2306); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the wand stopped working properly during a hip arthroscopy procedure.The wand was replaced and the case was completed.Upon examination of the defective wand, it was noticed that the metallic faceplate was missing.The broken piece could not be located, however, it did not show up on a fluoroscopic image.No patient injury or other complications were reported.

Manufacturer Narrative

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.Factors not associated with the manufacture or design of the device which could result in damage to the tip could be the device coming into abrupt contact with a hard (metallic) object, improper insertion or removal from an apparatus, use at a higher than recommended set point or excessive force applied to the tip can also lead to unintended detachment and are outlined in the precautionary statements in the instruction for use (¿ifu¿).There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

Manufacturer Narrative

Visual inspection under magnification shows the electrodes have been completely detached in conjunction with the spacer has been chipped off in the center of the spacer.There is a significant amount of scratch marks on the exposed shaft and the black shrink tube has been partially detached near the tip which is consistent with coming into contact with another metallic object.There are no manufacturing abnormalities visually observed with the returned device.Due to the detached electrodes and damage to the spacer a functional evaluation could not be conducted.The complaint has been visually verified and the root cause was more than likely associated with the device potentially coming into contact with a metal object such as a cannula.It is also possible that mechanical displacement of tissue through applied force or using the device as a lever to enlarge a surgical site or gain access to tissue can also cause this type of failure.The instruction for use (¿ifu¿) outlines warnings and precautionary measures to adhere to during activation of the device.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: AMBIENT HIPVAC 50 IFS
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: jim gonzales ; 7000 w. william cannon; austin, TX 78735
• MDR Report Key: 6490944
• MDR Text Key: 72962359
• Report Number: 3006524618-2017-00091
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K083306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASHA4730-01
• Device Lot Number: 1134398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1