MAUDE Adverse Event Report: MEDLINE RENEWAL Medline; ASHA 4250-01 AMBIENT ARTHROW SUPER TUR

Model Number ASHA42500RH

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/16/2023

Event Type  Injury  

Event Description

According to the customer on (b)(6) 2023 the ablation wand was flaking off inside the patient during a surgical procedure.

Manufacturer Narrative

According to the customer on (b)(6) 2023 the ablation wand was flaking off inside the patient during a surgical procedure.Per the facility the incident occurred "about 45 minutes" into the device being used.Per the facility "the surgeon took the burr and removed the flakes and finished the case with the same device".No additional information is available at this time.The sample was returned for evaluation and the reported issue could not be confirmed, therefore, a definitive root cause could not be determined at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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: ASHA 4250-01 AMBIENT ARTHROW SUPER TUR
• 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: 16525033
• MDR Text Key: 311133241
• Report Number: 3032391-2023-00002
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 10888277669895
• UDI-Public: 10888277669895
• 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: Other
• Type of Report: Initial
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ASHA42500RH
• Device Catalogue Number: ASHA42500RH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2023
• Date Manufacturer Received: 02/16/2023
• 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): Other