MAUDE Adverse Event Report: COVIDIEN LLC XPS BLADE; BUR, EAR, NOSE AND THROAT

Model Number 1882905HRE

Device Problem Material Fragmentation (1261)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 05/05/2021

Event Type  Injury  

Manufacturer Narrative

There were 2 devices used in the surgery and we're submitting 2 mdrs for the same event list of products involved: blade,silver bullet,2.9mm,m4 rotat,w/irr lot no.221527812 blade,silver bullet,2.9mm,m4 rotat,w/irr lot no.221527812.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by a health care professional that a silver bullet blade was used to trim the sinus turbinate and the piece inside the blade broke off.They replaced with another blade with the same lot number and it broke as well.An x ray was done as protocol at the end of the case to make sure nothing was in the nose; it was confirmed that nothing remained in the nose.The procedure was completed with backup product(s) with 30mins delay.There was no patient impact.Upon follow up it was reported that x-ray was done specifically to check for fragments.The part of the blade that broke was distal tip.There were fragments detached from the broken blade that fell into the patient.The anesthesia had to delay waking the patient up so an x-ray could be performed to make sure no fragments remained in the sinuses.

• Brand Name: XPS BLADE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer Contact: david gustafson ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635149628
• MDR Report Key: 11913137
• MDR Text Key: 253520421
• Report Number: 9612501-2021-00873
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00763000036782
• UDI-Public: 00763000036782
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1882905HRE
• Device Catalogue Number: 1882905HRE
• Device Lot Number: 0221527812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2021
• Initial Date FDA Received: 06/01/2021
• Date Device Manufactured: 01/15/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 77