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

Model Number ASC425001RH

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/12/2022

Event Type  Injury  

Event 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'.

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
• Type of Device: 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
• MDR Text Key: 297406980
• Report Number: 3032391-2022-00010
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 10888277380066
• UDI-Public: 10888277380066
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention