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

Catalog Number	ASHA4730-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a surgery the ambient hipvac 50 ifs electrode came off the handle into the patient.It was a piece of about 0.5 cm complete white part + electrode.The duration of the procedure was extended (unknown how much).The procedure was completed with another device.No other complications were reported.
Additional Manufacturer Narrative
B4: information added.Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a psoas tenotomy on hip prosthesis the ambient hipvac 50 ifs electrode came off the handle into the patient.It was a piece of about 0.5 cm complete white part + electrode.The device broke inside the patient it was retrieved using suction.The duration of the procedure was extended (unknown how much).The procedure was completed with a backup device.No other complications were reported.
Additional Manufacturer Narrative
B5 and health effect - impact code updated.H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.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.Our clinical investigation concluded: attempts to obtain medical documents were unsuccessful and thus a thorough medical investigation was not performed.Factors that could have contributed to the reported event include: (1) hitting the device tip against a hard surface.(2) using the device as a lever to enlarge surgical site.(3) mechanical displacement of tissue through applied force.(4) activating the device above recommended settings for prolonged periods of time.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Event or Problem Description
It was reported that during a psoas tenotomy on hip prosthesis the ambient hipvac 50 ifs electrode came off the handle into the patient.It was a piece of about 0.5 cm complete white part and the electrode.The broken piece was retrieved from the patient by suction.The duration of the procedure was extended but it is unknown for how long.The procedure was completed with a backup device.No other complications were reported.

• 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: 12594762
• Report Number: 3006524618-2021-00960
• Device Sequence Number: 11586337
• Product Code: GEI
• UDI-Device Identifier: 00817470000436
• UDI-Public: 817470000436
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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 Catalogue Number: ASHA4730-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 10/12/2021; 12/22/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 10/13/2021; 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown