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	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
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 tested pre-operatively on 11may2022 for a total laparoscopic hysterectomy procedure when it was reported ¿that the l-hook electrode came off after the electrode was moved in and out of the cannula several times during the pre-operative check.¿ the procedure was completed with an alternate unknown device.There was no impact or injury to the patient or user.On may 19th additional information was received from the distributor.¿it was reported that the hook had come off from the facility, but when the agency observed the actual product, it was said that the coating on the hook was missing.¿ on may 24th it was reported that ¿the device was observed and found the coating was peeled and detached, also the position of the insulation tube was misaligned and damaged.¿ 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.
Additional Manufacturer Narrative
Received one 60-5274-132 in opened original packaging.Lot number was verified.Performed a visual inspection, the black insulator is pulling off from the l-hook.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.A 2 year lot history review was conducted and found 2 events for the reported lot number and failure mode.A two-year review of complaint history revealed there has been a total of 20 reports, regarding 27 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: 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.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.
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 tested pre-operatively on 11may22 for a total laparoscopic hysterectomy procedure when it was reported ¿that the l-hook electrode came off after the electrode was moved in and out of the cannula several times during the pre-operative check.¿ the procedure was completed with an alternate unknown device.There was no impact or injury to the patient or user.On may 19th additional information was received from the distributor.¿it was reported that the hook had come off from the facility, but when the agency observed the actual product, it was said that the coating on the hook was missing.¿ on may 24th it was reported that ¿the device was observed and found the coating was peeled and detached, also the position of the insulation tube was misaligned and damaged.¿ this report is being raised on the basis of 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 14601148
• Report Number: 1320894-2022-00122
• Device Sequence Number: 6176884
• Product Code: GEI
• UDI-Device Identifier: 30653405010733
• UDI-Public: (01)30653405010733(17)261219(10)202112201
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2022

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: 202112201
• 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: 05/17/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic