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

Model Number	60-5274-032
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Conmed (b)(4) reported on behalf of their customer that the 60-5274-032, spatula electrod w/stealth er 5mm x 32cm (5/cs), was being used during a total laparoscopic hysterectomy on (b)(6) 2022 when it was reported that the ¿tip of electrode was detached during the surgery.¿ further assessment found the procedure was completed and there was no delay to the surgery reported.The tip of the device was in the sterile field when it became detached from the device and fell into the surgical site.The tip was retrieved using grasping forceps.There was no report of injury, medical/surgical intervention or extended hospitalization required for the patient.The patient¿s current status is unknown.This report is being raised on the basis of 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.This issue will continue to be monitored through the complaint system to assure patient safety.Device not yet recieved.
Additional Manufacturer Narrative
Received one 60-5274-032 in unoriginal packaging.Lot number was not verified.Performed a visual inspection, the spatula electrode was received disassembled from the device.There is evidence of soldering on the electrode.The potential root cause was identified to be the loss of energy from the laser input controller to the output beam.Fiber optic cable damage/loss, and laser misalignment over time were determined to be contributing factors to energy loss throughout the system.Upon operations notification of weak weld strength, the welder manufacturer serviced the equipment to correct the energy loss/misalignment issue.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.(b)(4).Per the instructions for use, the user is advised to examine the device prior to use for damage.Do not use if damage is found.These electrosurgical suction/irrigation instruments should only be used by surgeons trained in surgical endoscopy according to established hospital protocol.To 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.Misuse of this device can result in a patient injury.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
Conmed japan reported on behalf of their customer that the 60-5274-032, spatula electrod w/stealth er 5mm x 32cm (5/cs), was being used during a total laparoscopic hysterectomy on (b)(6) 2022 when it was reported that the ¿tip of electrode was detached during the surgery.¿ further assessment found the procedure was completed and there was no delay to the surgery reported.The tip of the device was in the sterile field when it became detached from the device and fell into the surgical site.The tip was retrieved using grasping forceps.There was no report of injury, medical/surgical intervention or extended hospitalization required for the patient.The patient¿s current status is unknown.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: courtney pomichter ; 525 french rd; utica, NY 13502 ; 3156243170
• MDR Report Key: 15029029
• Report Number: 1320894-2022-00153
• Device Sequence Number: 6196415
• Product Code: GEI
• UDI-Device Identifier: 30653405010702
• UDI-Public: (01)30653405010702(17)261205(10)202112061
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2022

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 Model Number: 60-5274-032
• Device Catalogue Number: 60-5274-032
• Device Lot Number: 202112061
• 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: 07/06/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic