MAUDE Adverse Event Report: CONMED UTICA SPATULA ELECTROD W/STEALTH ER 5MM X 32CM (5/CS); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	60-5274-032
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Conmed australia reported on behalf of the customer that the 60-5274-032, spatula electrod w/stealth er was being used on (b)(6) 2023 during an unknown procedure and that the ¿spatula tip end broke off inside patient while operating.Immediately replaced item for surgeons after they retrieved the tip from inside the patient.".There was no impact or injury to the patient.The procedure was completed with an alternate unknown device.There was a 2 minute delay to the procedure.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Additional Manufacturer Narrative
Received one (b)(4) in opened original packaging.The lot number was verified.Performed a visual inspection, the spatula electrode was returned disassembled from the device.There is soldering present on the electrode.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 28 reports, regarding 29 devices, for this device family and failure mode.During this same time frame 257,650 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 0.0001.Per the instructions for use, the user is advised the following: avoid potential damage to trocar seals and to the electrosurgical tip, always slide the tip shield in the covered and locked position during insertion into the trocar cannula.Examine this device prior to use for damage.Do not use if damage is found.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
Conmed australia reported on behalf of the customer that the (b)(4), spatula electrod w/stealth er was being used on (b)(6) 23 during an unknown procedure and that the ¿spatula tip end broke off inside patient while operating.Immediately replaced item for surgeons after they retrieved the tip from inside the patient.".There was no impact or injury to the patient.The procedure was completed with an alternate unknown device.There was a 2 minute delay to the procedure.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: SPATULA ELECTROD W/STEALTH ER 5MM X 32CM (5/CS)
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 17412589
• Report Number: 1320894-2023-00144
• Device Sequence Number: 7037909
• Product Code: GEI
• UDI-Device Identifier: 30653405010702
• UDI-Public: (01)30653405010702(17)270724(10)202207251
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K952204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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: 60-5274-032
• Device Lot Number: 202207251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic