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

Catalog Number	ASC425001RH
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the tip of the ablation electrode detached during a shoulder joint procedure and fell into the surgical site.The detached tip was successfully retrieved from the surgical site using forceps.A new device was obtained and the procedure was completed without further reported incident.There was no reported adverse impact to the patient.A sample has been received and investigation is ongoing.Due to the reported need for medical intervention to retrieve the detached tip from the surgical site, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the tip of the ablation electrode fell off during use.
Additional Manufacturer Narrative
Investigation of the returned sample from the reporting facility has been completed.The electrode faceplate was noted to have detached from the tip.Burn marks were observed on the top of the electrode tip and ceramic.The damaged electrode faceplate appear to be due to over activation by the end-user.The root cause for the reported incident was found to be use error.If additional relevant information becomes available another supplemental mdr will be filed.

• Common Device Name: ASC 4250-01 @SUPER TURBOVAC 90, 90 DEGRE
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock avenue; redmond, or
• MDR Report Key: 9771379
• Report Number: 3032391-2020-00002
• Device Sequence Number: 2952424
• Product Code: NUJ
• UDI-Device Identifier: 10888277380066
• UDI-Public: 10888277380066
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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 Catalogue Number: ASC425001RH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 03/03/2020
• 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
• Patient Age: 50 YR