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

Model Number 1884006EM

Device Problems Break (1069); Vibration (1674)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A healthcare provider (hcp) reported that during a fess procedure the blade broke.It seemed to be shaking toward the end of use during the case and had not been in use for very long.When they went to swap to a different blade they found the tip had been broken.Nothing broke off in the patient and no patient harm or delay to the clinical case.

• Brand Name: XPS SYSTEM NAVIGATED BLADE
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer Contact: tricha miles ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635140379
• MDR Report Key: 10701778
• MDR Text Key: 213651151
• Report Number: 9612501-2020-01487
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00763000043254
• UDI-Public: 00763000043254
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2022
• Device Model Number: 1884006EM
• Device Catalogue Number: 1884006EM
• Device Lot Number: 0219215915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/19/2020
• Date Device Manufactured: 01/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 102