MAUDE Adverse Event Report: CONMED LARGO E9000; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	E8230LSO
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A sales representative reported on behalf of a customer that the e8230lso, e9000 fluted low speed optimum bur, round, carbide, 3 x 48 mm device was used in an ear procedure on (b)(6)2024, and ¿during a ent surgery, surgeon was using coolflex with our bur when the head of the bur broke inside the patient.Fortunately, they can removed with no issues for the patient.".The procedure was completed with an alternate same device, and a delay of 15 minutes.There was no report of injury, medical/surgical intervention or extended hospitalization required for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
A sales representative reported on behalf of a customer that the e8230lso, e9000 fluted low speed optimum bur, round,carbide,3 x 48 mm device was used in an ear procedure on (b)(6) 2024, and ¿during a ent surgery, surgeon was using coolflex with our bur when the head of the bur broke inside the patient.Fortunately, they can removed with no issues for the patient.".The procedure was completed with an alternate same device, and a delay of 15 minutes.There was no report of injury, medical/surgical intervention or extended hospitalization required for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, the reported event cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of six reports, regarding six devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised to avoid contact with cutting tip of blade or bur when locking into handpiece.Tips are sharp and may cause injury.Do not use burs for plunge cutting.Injury or damage may occur.Always inspect for bent, dull or damaged blades or burs before each use.Do not attempt to straighten or sharpen.Do not use if damaged.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: E9000
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 20682856
• Report Number: 1017294-2024-00130
• Device Sequence Number: 7281475
• Product Code: GFF
• UDI-Device Identifier: 10845854010426
• UDI-Public: (01)10845854010426(17)290423(10)1385338
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: E8230LSO
• Device Lot Number: 1385338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic