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

Model Number	1882905HRE
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	05/05/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• MDR Report Key: 11913137
• Report Number: 9612501-2021-00873
• Device Sequence Number: 19160096
• Product Code: EQJ
• UDI-Device Identifier: 00763000036782
• UDI-Public: 00763000036782
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2025
• Device Model Number: 1882905HRE
• Device Catalogue Number: 1882905HRE
• Device Lot Number: 0221527812
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Weight: 77