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

Catalog Number	72290004
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip surgery, the device tip broke off into the patient.Physician attempted to retrieve but was unable to visualize, given small fragment, though not likely to cause harm.The procedure was successfully completed but it is unknown if it was completed with the same device or another device without significant delay.Patient injuries were not reported.
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.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.

• 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: 8725698
• Report Number: 3006524618-2019-00302
• Device Sequence Number: 14008472
• Product Code: GEI
• UDI-Device Identifier: 00885556614686
• UDI-Public: 00885556614686
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K161481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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: 02/02/2022
• Device Catalogue Number: 72290004
• Device Lot Number: 2027210
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 06/23/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 82