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

Model Number	ASHA4730-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a hip arthroscopy surgery a small ring of white plastic had become detached from the tip of the wand.The loose plastic part was successfully removed from the patient's body using a cannula (suctioned).No patient injuries or significant delay reported.Back-up device was available to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.A review of manufacturing records for the reported lot number found no non-conformance's or anomalies during manufacturing process related to the reported event.A complaint history review found no related failures; this failure mode will be trended to assess for any necessary corrective actions.Visual inspection under magnification shows minimal erosion of the screen/electrodes with scratch/scuff marks on the spacer and return electrode.Additionally the adhesive that surrounds the top part of the spacer is detached and was not returned for evaluation.There are no manufacturing abnormalities visually observed with the returned device.Prior to activation r2 was measured with 1503 ohms after bypassing the error e-7 the device produced plasma on ablate/coag min./max.Settings as intended; the suction line was clogged, a backflush could clean the line.The complaint was verified.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: (1) hitting the device tip against a hard surface such as an insertion cannula and/or (2) using the device as a lever to enlarge surgical site (3) mechanical displacement of tissue through applied force.No containment or corrective actions are recommended at this time.There were no indications during manufacturing record review that would suggest that the devices did not meet product specifications upon release into distribution.

• 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
• MDR Report Key: 9919342
• Report Number: 3006524618-2020-00144
• Device Sequence Number: 19615860
• Product Code: GEI
• UDI-Device Identifier: 00817470000436
• UDI-Public: 00817470000436
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083306
• 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
• Report Date (Section B): 05/04/2020

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: 04/28/2022
• Device Model Number: ASHA4730-01
• Device Catalogue Number: ASHA4730-01
• Device Lot Number: 2031927
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1