MAUDE Adverse Event Report: COVIDIEN LLC XPS SYSTEM NAVIGATED BLADE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	1884006EM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis found that there was a residue consistent with biological contaminants on the device.Visually, the middle rotating assembly tip was broken at the distal end.The information most likely indicates an interference issue of the diameters during manufacturing, ultimately resulting in the reported event; however, the customer did report catching a pledget, causing the failure prematurely.Functionally, the middle assembly did have significant resistance.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare professional (hcp) reported that the blade tip broke into multiple pieces during the fess (functional endoscopic sinus surgery) procedure.The tip of the blade did not break off in the patient.There was no unplanned procedures or unintended equipment required to locate and remove the fragments.There was no pieces remain in the patient.They believe that the impact on the pledget cause the teeth of the blade to jam leading to the break.The blade was running at the speed of 5000.There was a delay with the procedure.There was a back-up device used.They were able to pull out the pieces from the patient prior to closing.There was no patient harm.

• Brand Name: XPS SYSTEM NAVIGATED BLADE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• MDR Report Key: 12281381
• Report Number: 9612501-2021-01297
• Device Sequence Number: 17095742
• Product Code: HAW
• UDI-Device Identifier: 00763000043254
• UDI-Public: 00763000043254
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

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 Expiration Date: 09/01/2022
• Device Model Number: 1884006EM
• Device Catalogue Number: 1884006EM
• Device Lot Number: 0220659888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 110