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

Catalog Number 60-5274-132

Device Problem Arcing (2583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The sales representative reported on behalf of the customer 60-5274-132, stealth 32 lhook lap elec pkg was being used during a laparoscopic cholecystectomy procedure on an unknown date when it was reported ¿¿we have been having an issue with the disposable l-hooks.60-5274-132.The doctor is saying it is arcing along the sheath and may be causing burns.This isn't the first time i heard this, nor the first time i mentioned this.She has the setting at 35, so it isn't cranked up.¿ further assessment questioning found that the patient was not diagnosed with a burn as well as ¿the potential arcing of the instrument has been mentioned prior, but only once.Do not recall the date.No surgery delay or patient injury.¿ the current status of the patient was reported as ¿discharged.¿.There was no report of injury, medical intervention, or hospitalization required for the patient.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The reported device has been returned to conmed.However, the evaluation of the device has not been completed.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.

Manufacturer Narrative

Reported event ¿arcing along the sheath and may be causing burns¿ was confirmed.Received one 60-5274-132 in opened original package.Lot number was not verified.Performed a visual inspection, the insulation within the lhook is delaminated.A two-year lot history review cannot be conducted as a lot number was not provided.A device history cannot be conducted as a lot number was not provided.A two-year review of complaint history revealed there has been a total of 3 complaints, regarding 3 devices, for this device family and failure mode.During this same time frame 241,520 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 0.00001.Per the instructions for use, the user is advised the following: always use the lowest possible setting to achieve the desired electrosurgical effect.Examine this device prior to use for damage.Do not use if damage is found.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer 60-5274-132, stealth 32 lhook lap elec pkg was being used during a laparoscopic cholecystectomy procedure on an unknown date when it was reported ¿we have been having an issue with the disposable l-hooks.(60-5274-132).The doctor is saying it is arcing along the sheath and may be causing burns.This isn't the first time i heard this, nor the first time i mentioned this.She has the setting at 35, so it isn't cranked up.¿ further assessment questioning found that the patient was not diagnosed with a burn as well as ¿the potential arcing of the instrument has been mentioned prior, but only once.Do not recall the date.No surgery delay or patient injury.¿ the current status of the patient was reported as ¿discharged.¿.There was no report of injury, medical intervention, or hospitalization required for the patient.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: STEALTH 32 LHOOK LAP ELEC PKG
• Type of Device: 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 16905688
• MDR Text Key: 315337065
• Report Number: 1320894-2023-00085
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60-5274-132
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2023
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic