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

Model Number 1884006EM

Device Problems Material Separation (1562); Vibration (1674)

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

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A health care provider reported via manufacturer representative that the blade prepared by short-term rental at endoscopic sinus surgery, and it is connected to the handpiece after opening, the external cylinder part of the blade was oscillating from the beginning and then comes off.It was felt that the blade was oscillating, but it seems that it was thought to have no problem because the blade could actually cut, and it was used.It couldn't be confirmed if it was "oscillating".It was the tip that came off, and it came off at the time of use after it was pulled out once and the blade and motor were reconnected.The procedure was delayed for 5-10 minutes.The procedure was completed with backup product(s).On follow up, it was reported that there were no fragments that came off or got detached from the device.There were no fragment that get in contact with the patient.The broken parts contained in the handpiece.The blade broke while being used in the patient.This was the initial use of the device.Additional information reported that the blade "oscillating" means wobbling.

Manufacturer Narrative

H3: analysis found that visually, the end of the shaft with the hub had been pushed out of the outer tube area indicating spiral wrap damage.In addition, the tip broke off and the middle assembly tip had been pushed out of the outer tube support area indicating spiral wrap damage.The shrink tubing may have been out of tolerance causing an interference fit.The information most likely indicates an interference issue of the diameters during manufacturing, ultimately resulting in the reported event.The inner blade was removed and spun on a flat raised surface.The hub appeared to be concentric.Using a concentricity gage the hub was found to be +/- 0.001¿.H6: the fdm b17, fdr c20 and fdc d14 no longer applies.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS SYSTEM NAVIGATED BLADE
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• MDR Report Key: 11670986
• MDR Text Key: 245561381
• Report Number: 9612501-2021-00613
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K130608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• 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: 0218311145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1