MAUDE Adverse Event Report: CONMED UTICA STEALTH 32 LHOOK LAP ELEC PKG; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	60-5274-132
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
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.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device, 60-5274-132, stealth 32 lhook lap elec pkg, was being used during a total laparoscopic hysterectomy on (b)(6) 2022 when it was reported ¿that the customer found peeling of the l-hook electrode coating during surgery.During the operation, they found peeling of the l hook coating before using it for the patient, so they prepared an alternative device, but it was also confirmed to peel off.Therefore, surgery was performed with the third device and completed without any problem.¿.A second device, same lot, experienced the same type of malfunction; however, a third, same-like device was used to complete the procedure.There was no report of fragmentation contact to the patient.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The customer reported that the device, 60-5274-132, stealth 32 lhook lap elec pkg, was being used during a total laparoscopic hysterectomy on (b)(6) 2022 when it was reported ¿that the customer found peeling of the l-hook electrode coating during surgery.During the operation, they found peeling of the l hook coating before using it for the patient, so they prepared an alternative device, but it was also confirmed to peel off.Therefore, surgery was performed with the third device and completed without any problem.¿.A second device, same lot, experienced the same type of malfunction; however, a third, same-like device was used to complete the procedure.There was no report of fragmentation contact to the patient.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.Update: (b)(6) 2022 - additional information was provided that peeling was found while using the device during surgery.
Additional Manufacturer Narrative
Received two 60-5274-132 in unoriginal packaging.Lot number was not verified.Performed a visual inspection, the complaint was confirmed.The black insulation is peeling off from the l-hook electrode.Based upon the evaluation and the photographs, the likely cause of this issue is the user activating the device continuously and at higher power than necessary.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 19 complaints, regarding 20 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 that these electrosurgical suction/irrigation instruments should only be used by surgeons trained in surgical endoscopy according to established hospital protocol.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.Always use the lowest possible settings to achieve the desired electrosurgical effect.Additionally, the ifu advises the user that this product is designed for non-continuous operation with a duty cycle of 10 seconds on and 30 seconds off.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: STEALTH 32 LHOOK LAP ELEC PKG
• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 13823719
• Report Number: 1320894-2022-00064
• Device Sequence Number: 16664964
• Product Code: GEI
• UDI-Device Identifier: 30653405010733
• UDI-Public: (01)30653405010733(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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2022

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: 60-5274-132
• Device Catalogue Number: 60-5274-132
• Device Lot Number: 202112061
• 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: 03/07/2022
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 03/19/2022
• Supplement Report FDA Received Date: 05/09/2022
• 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