MAUDE Adverse Event Report: MEDLINE RENEWAL; ARTHROCARE AMBIENT¿ SUPER TURBOVAC¿ 90° 90°SUCTION IFS 3.75 MM

Model Number	ASHA 4250-01
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a shoulder arthroscopy, the metal modes of the reprocessed arthrocare ambient¿ super turbovac¿ were noted to be missing.Reportedly, the surgical site was searched and the patient's shoulder was irrigated.A c-arm x-ray was reportedly used to confirm that no metal was retained in the shoulder.General anesthesia was used and there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.There was no serious injury or follow-up care reported related to this event.Due to the reported incident and in an abundance of caution, this medwatch is being filed.The sample is not available to be returned for evaluation.The lot number associated with the device was not reported.A review of the reprocessing record could not be performed.A root cause cannot be identified at this time.No additional information is available.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a shoulder arthroscopy, metal modes of the reprocessed ambient¿ super turbovac¿ were noted to be missing requiring irrigation of the surgical site.

• Common Device Name: ARTHROCARE AMBIENT¿ SUPER TURBOVAC¿ 90° 90°SUCTION IFS 3.75 MM
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• MDR Report Key: 8150468
• Report Number: 3032391-2018-00021
• Device Sequence Number: 13854593
• Product Code: NUJ
• UDI-Device Identifier: 10888277669895
• UDI-Public: 10888277669895
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/11/2018

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 Model Number: ASHA 4250-01
• Device Catalogue Number: REP110847
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/11/2018
• 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: Other
• Patient Age: 63 YR