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 Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer reported that the 60-5274-032, spatula electrod w/stealth er 5mm x 32cm (5/cs), was being used during an unknown procedure on (b)(6) 2024 when it was reported ¿the spatula electrode was detached and fell off during the surgery.¿.It was also reported that ¿the electrode fell out into the patient's body and was removed using croce forceps (intestine forceps).¿.There was no report of injury, medical intervention, or prolonged hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received one 60-5274-032 in unoriginal packaging.Lot number was not verified.Performed a visual inspection, the spatula tip is disconnected from the device.There is soldering present on the electrode.A root cause cannot be determined, however, based upon the instructions for use; a possible cause of this event could be the use of excessive force during surgery.A secondary cause could be that the electrode tip was not covered and was damaged during trocar insertion.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.(b)(4).Per the instructions for use, the user is advised that misuse of this or any other electrosurgical device can result in a patient injury.Read and become familiar with all instructions and directions before using this device.During trocar insertion, always have the electrode tip covered to avoid potential damage to trocar seals and the electrode tip.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the 60-5274-032, spatula electrod w/stealth er 5mm x 32cm (5/cs), was being used during an unknown procedure on (b)(6) 2024 when it was reported "the spatula electrode was detached and fell off during the surgery." it was also reported that "the electrode fell out into the patient's body and was removed using croce forceps (intestine forceps)." there was no report of injury, medical intervention, or prolonged hospitalization for the patient.This report is being raised on the basis of 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 18929067
• Report Number: 1320894-2024-00072
• Device Sequence Number: 11890574
• Product Code: GEI
• UDI-Device Identifier: 30653405010702
• UDI-Public: (01)30653405010702(17)280325(10)202303271
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K952204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2024

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: 60-5274-032
• Device Lot Number: 202303271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic