MAUDE Adverse Event Report: CONMED UTICA CONMED; ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

Catalog Number	60-5180-104
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A sales representative reported on behalf of a customer that the 60-5180-104, electrosurgical accessory,loop excision electrode device was being used during a leep procedure on (b)(6) 2024, and the ¿loop electrode broke during resection of the tissue.¿ the procedure was completed without the use of an alternate device, and there was no delay.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.However, follow-up assessment found that "loop broke in the middle with sides still attached." it is unknown if any fragmentation fell into the surgical site.Per sales representative, "could not locate the piece that was missing after patient exam.Compared broken device to intact device.After visual exam.Could not locate broken pieces.Size of electrode piece that was broken was the size of an eyelash making it very difficult to locate.Nothing was removed." the patient's current condition is reportedly "stable, no harm known at this point." this report is being raised due to the reported injury of fragmentation; although not found in the patient, they cannot produce the piece and its location is unknown.
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.
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.A two-year lot history review shows a total of (b)(4) device for this lot number and failure mode.(b)(4).Per the instructions for use, the user is advised to inspect and test each device before each use.These devices should be inspected before and after each use.Visually examine the devices for obvious physical damage including: cracked, broken or otherwise distorted plastic parts.Damage including cuts, punctures, nicks, abrasions, unusual lumps, significant discoloration.Verify that the electrode is fully and securely seated in the handpiece before use.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 60-5180-104, electrosurgical accessory, loop excision electrode device was being used during a leep procedure on (b)(6) 2024, and the ¿loop electrode broke during resection of the tissue.¿.The procedure was completed without the use of an alternate device, and there was no delay.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.However, follow-up assessment found that "loop broke in the middle with sides still attached.".It is unknown if any fragmentation fell into the surgical site.Per sales representative, "could not locate the piece that was missing after patient exam.Compared broken device to intact device.After visual exam.Could not locate broken pieces.Size of electrode piece that was broken was the size of an eyelash making it very difficult to locate.Nothing was removed.".The patient's current condition is reportedly "stable, no harm known at this point.".This report is being raised due to the reported injury of fragmentation; although not found in the patient, they cannot produce the piece and its location is unknown.

• Brand Name: CONMED
• Common Device Name: ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 20148269
• Report Number: 1320894-2024-00226
• Device Sequence Number: 8301904
• Product Code: HGI
• UDI-Device Identifier: 30653405010238
• UDI-Public: (01)30653405010238(17)270130(10)202201311
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K925333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 60-5180-104
• Device Lot Number: 202201311
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic