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

Catalog Number	60-5274-132
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	10/20/2023
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.H3 other text : device not yet received.
Event or Problem Description
The customer reported that the device, 60-5274-132, stealth 32 lhook lap elec pkg, was being used during an unknown procedure on (b)(6)2023 when it was reported, ¿it was reported that the insulation cover detached from the cannula.¿.There was no report of injury, medical intervention, or hospitalization for the patient.There was no report of fragmentation of the device and no component fell into the surgical site.The procedure was completed using a alternate, same device and there was no report of procedure delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received one 60-5274-132 in opened original package.Lot number was verified.Performed a visual inspection, the complaint was confirmed.The insulation cover detached from the cannula.The root cause cannot be determined, however, based upon the photos and the ifu, the likely cause is due to damage incurred during sliding the hook in and out of the sheath.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 2 devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 43 complaints, regarding 51 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 the following: 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.Examine this device prior to use for damage.We will continue to monitor for trends 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 an unknown procedure on (b)(6) 2023 when it was reported, ¿it was reported that the insulation cover detached from the cannula¿.There was no report of injury, medical intervention, or hospitalization for the patient.There was no report of fragmentation of the device and no component fell into the surgical site.The procedure was completed using a alternate, same device and there was no report of procedure delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• 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: 18064062
• Report Number: 1320894-2023-00242
• Device Sequence Number: 20700207
• Product Code: GEI
• UDI-Device Identifier: 30653405010733
• UDI-Public: (01)30653405010733(17)280401(10)202304031
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

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: 60-5274-132
• Device Lot Number: 202304031
• 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: 10/24/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic