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

Model Number	ASHA4730-01
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during arthroscopy procedure, outside the patient, the ambient hipvac 50 ifs was chipping off parts, there were black parts in the joint in as well.It had a black insulation on the shaft and parts of it have detached and are in the joint where they were removed.The procedure was successfully completed without significant delay using a back-up device.No patient injury or other complications were reported.
Event or Problem Description
It was reported that during arthroscopy procedure, the black insulation on the shaft of the ambient hipvac 50 ifs was chipping off parts.Some of those black parts were in the joint and were removed from the patient.The procedure was successfully completed without significant delay using a back-up device.No other complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was not received, but six sample devices from the same batch were received for evaluation.A visual inspection found six sealed and unopened devices.The devices were opened and the returned instruments showed no manufacturing abnormalities.Insulation is intact and no deficiencies were observed.It was determined the device did not contribute to the reported event.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.Factors which could have contributed to the reported event include excessive force applied to the insulation by other surgical instruments.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: AMBIENT HIPVAC 50 IFS
• Common Device Name: 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: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12603009
• Report Number: 3006524618-2021-00963
• Device Sequence Number: 19880212
• Product Code: GEI
• UDI-Device Identifier: 00817470000436
• UDI-Public: 00817470000436
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/26/2023
• Device Model Number: ASHA4730-01
• Device Catalogue Number: ASHA4730-01
• Device Lot Number: 2062490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 10/10/2021
• Supplement Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown