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

Model Number	60-5274-132
Medical Device Problem Codes	Material Fragmentation (1261); Peeled/Delaminated (1454)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Conmed (b)(6) reported on behalf of their customer that the device, 60-5274-132, stealth 32 lhook lap elec pkg was being used on (b)(6) 2022 during a total laparoscopic hysterectomy procedure when it was reported ¿that the tip coating or insulation tube of l-hook electrode was peeled off during the surgery.Therefore, the use of that device was discontinued.¿ there was no impact or injury to the patient or user.There was no report of medical intervention or any prolonged hospitalization for the patient.An alternate device of the same was used to complete the procedure.Further assessment found that the procedure was delayed approximately 1 to 1.5 hours and it is unknown if a fragment fell into the surgical site.¿cleaning was performed more than usual.¿ this report is being raised on the basis of potential injury based upon the lack of information regarding if fragments fell into the patient and potentially remain.
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
Conmed japan reported on behalf of their customer that the device, 60-5274-132, stealth 32 lhook lap elec pkg was being used on 2jun22 during a total laparoscopic hysterectomy procedure when it was reported ¿that the tip coating or insulation tube of l-hook electrode was peeled off during the surgery.Therefore, the use of that device was discontinued.¿ there was no impact or injury to the patient or user.There was no report of medical intervention or any prolonged hospitalization for the patient.An alternate device of the same was used to complete the procedure.Further assessment found that the procedure was delayed approximately 1 to 1.5 hours and it is unknown if a fragment fell into the surgical site.¿cleaning was performed more than usual.¿ this report is being raised on the basis of potential injury based upon the lack of information regarding if fragments fell into the patient and potentially remain.
Additional Manufacturer Narrative
Received one 60-5274-132 in original opened package.Lot number was verified.Performed a visual inspection, the tip of the electrode was peeling.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 15 reports, regarding 22 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: examine this device prior to use for damage.Do not use if damage is found.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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 14735081
• Report Number: 1320894-2022-00129
• Device Sequence Number: 2226835
• Product Code: GEI
• UDI-Device Identifier: 30653405010733
• UDI-Public: (01)30653405010733(17)270119(10)202201201
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 60-5274-132
• Device Catalogue Number: 60-5274-132
• Device Lot Number: 202201201
• 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: 06/02/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic