MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS SYSTEM NAVIGATED BLADE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 1884006EM

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2021

Event Type  malfunction  

Manufacturer Narrative

There were 3 devices used in the surgery and we are submitting 3 mdrs for the same event.List of products involved: blade 1884006em rad40 4mm m4 rotate lot # 218356289 blade 1884006em rad40 4mm m4 rotate lot # 218356289 blade 1884006em rad40 4mm m4 rotate lot # 218356289.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by a health care professional that during endoscopic sinus surgery, the blade tip was damaged.There was no patient impact.The device had in contact with the patient and there was no broken pieces of the reported product remain inside the patient's body.The procedure was completed with back up device.Upon follow up it was reported that the device damaged while being used on a patient.There were fragments detached/came off from the broken device that fell into the patient but all were collected.The damaged part was retrieved using forceps while looking through an endoscope.The doctor checked the inside of the nose with the endoscope and confirmed that there were no leftovers.

• Brand Name: XPS SYSTEM NAVIGATED BLADE
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: david gustafson ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635149628
• MDR Report Key: 12126999
• MDR Text Key: 260306590
• Report Number: 1045254-2021-00348
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2021

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
• Device Operator: Health Professional
• Device Model Number: 1884006EM
• Device Catalogue Number: 1884006EM
• Device Lot Number: 0218356289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 07/07/2021
• Date Device Manufactured: 12/10/2019
• 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