MAUDE Adverse Event Report: MEDLINE RENEWAL; ARTHROCARE STARVAC¿ ARTHROWAND¿, 90 DEGREE, W/INTEGRATED CABLE, SUCTION (GREY)

Model Number	ASC 4251-01
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the tip of a reprocessed arthrocare wand fell apart inside of a patient during use.Per report, the physician was able to locate and successfully retrieve all the broken pieces from the patient through an unknown method.The reporting facility stated that they were able to grab another device and the surgery commenced without further incident.There was no report of serious injury, adverse patient consequence or prolonged anesthesia related to the incident.Due to the reported incident and in an abundance of caution, renewal is filing this medwatch report.The sample was returned for evaluation and it was confirmed that the device was reprocessed.The reported issue that the tip had broken off of the device was confirmed.A root cause could not be determined at this time.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the tip of a reprocessed arthrocare wand fell apart inside of a patient during use.

• Common Device Name: ARTHROCARE STARVAC¿ ARTHROWAND¿, 90 DEGREE, W/INTEGRATED CABLE, SUCTION (GREY)
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• MDR Report Key: 7777241
• Report Number: 3032391-2018-00009
• Device Sequence Number: 11240521
• Product Code: GEI
• UDI-Device Identifier: 10888277380066
• UDI-Public: 10888277380066
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2018

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: 06/30/2020
• Device Model Number: ASC 4251-01
• Device Catalogue Number: REP103688
• Device Lot Number: 346724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention