MAUDE Adverse Event Report: CONMED UTICA STEALTH 44 LHOOK LAP ELEC PKG; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	60-5274-144
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	12/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported event is inconclusive.The device will not be returned for evaluation and no photographic evidence has been provided; therefore, the reported event cannot be verified.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 was conducted and found 3 other similar events reported for this lot number involving 4 devices for this lot; however, none have been confirmed.A two-year review of complaint history revealed there has been a total of 13 complaints, regarding 13 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 0.00006.Per the instructions for use, the user is advised the following: to avoid damage to the trocar seals and to the electrosurgical tip, always slide the tip shield in the covered and locked position during insertion into the trocar cannula.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.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, (b)(4), stealth 44 lhook lap elec pkg was being used on (b)(6) 2021 during a bariatric procedure and "electrode fell into the patient¿s abdominal cavity upon insertion.It was fished out and retrieved by the surgeon." there was a delay of 2 minutes.The procedure was completed with an alternate same device.There was no impact or injury to the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Report was updated to reflect the device evaluation.Type of investigation was updated from device not returned to device returned.Investigation findings updated from no findings available to fracture problem manufacturer narrative: reported event of electrode detaching is confirmed.Received one 60-5274-144 in opened original packaging.Lot number was verified.Performed a visual inspection, the electrode is not attached to the device.Soldering is present on the electrode.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 was conducted and found 3 other similar events reported for this lot number involving 4 devices for this lot; however, only one has have been confirmed.A two-year review of complaint history revealed there has been a total of 13 complaints, regarding 13 devices, for this device family and failure mode.During this same time frame 231,855 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 0.00006.Per the instructions for use, the user is advised the following: to avoid damage to the trocar seals and to the electrosurgical tip, always slide the tip shield in the covered and locked position during insertion into the trocar cannula.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.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 60-5274-144, stealth 44 lhook lap elec pkg was being used on (b)(6) 2021 during a bariatric procedure and ¿electrode fell into the patient¿s abdominal cavity upon insertion.It was fished out and retrieved by the surgeon.¿ there was a delay of 2 minutes.The procedure was completed with an alternate same device.There was no impact or injury to the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Correction: e1 was changed to the correct address.Reported event is inconclusive.The device will not be returned for evaluation and no photographic evidence has been provided; therefore, the reported event cannot be verified.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 was conducted and found 3 other similar events reported for this lot number involving 4 devices for this lot; however, none have been confirmed.A two-year review of complaint history revealed there has been a total of 13 complaints, regarding 13 devices, for this device family and failure mode.During this same time frame 231,855 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 0.00006.Per the instructions for use, the user is advised the following: to avoid damage to the trocar seals and to the electrosurgical tip, always slide the tip shield in the covered and locked position during insertion into the trocar cannula.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.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 60-5274-144, stealth 44 lhook lap elec pkg was being used on (b)(6) 2021 during a bariatric procedure and ¿electrode fell into the patient¿s abdominal cavity upon insertion.It was fished out and retrieved by the surgeon.¿ there was a delay of 2 minutes.The procedure was completed with an alternate same device.There was no impact or injury to the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: STEALTH 44 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: 13117220
• Report Number: 1320894-2021-00462
• Device Sequence Number: 4518067
• Product Code: GEI
• UDI-Device Identifier: 30653405010740
• UDI-Public: (01)30653405010740(17)260606(10)202106071
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K952204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2022

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 Expiration Date: 06/06/2026
• Device Model Number: 60-5274-144
• Device Catalogue Number: 60-5274-144
• Device Lot Number: 202106071
• 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: 12/03/2021
• Supplement Date Received by Manufacturer: 12/03/2021; 03/11/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 12/31/2021; 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic