MAUDE Adverse Event Report: MEDLINE RENEWAL Medline; ASC 4250-01 SUPER TURBOVAC 90,90 DEGRE

Model Number	ASC425001RH
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) 2022 during the middle of a procedure on the patient's right shoulder 'the bead on the end of the wand fell off into the patient and had to be removed with a grasper'.
Additional Manufacturer Narrative
According to the facility on (b)(6) 2022 during the middle of a procedure on the patient's right shoulder 'the bead on the end of the wand fell off into the patient and had to be removed with a grasper'.Per the facility all pieces were accounted for and the surgeon discontinued the use of the device and finished the procedure with a new device.Per the facility the procedure was completed and there was no noted impact to the patient.The device was returned for evaluation and a definitive root cause could not be determined at this time.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline
• Common Device Name: ASC 4250-01 SUPER TURBOVAC 90,90 DEGRE
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15178229
• Report Number: 3032391-2022-00010
• Device Sequence Number: 17695322
• Product Code: NUJ
• UDI-Device Identifier: 10888277380066
• UDI-Public: 10888277380066
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/05/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: ASC425001RH
• Device Catalogue Number: ASC425001RH
• Device Lot Number: 477702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown