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 an unknown 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 ¿i don¿t have details about a second occurrence.The account contact only mentioned that he ¿had heard this happened before¿.I don¿t have a date, surgeon name, or type of procedure.However, i am under the impression that there was no significant burn / injury, no treatment of the burn or intervention necessary.¿ 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 device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.

Manufacturer Narrative

The device will not be returned and no photographic evidence has been provided therefore the reported event cannot be verified.A device history review could not be conducted as a lot number was not provided.(b)(4).Per the instructions for use, the user is advised the following: this product is designed for non-continuous operation, with a duty cycle of 10 seconds on, and 30 seconds off.Always use the lowest possible setting to achieve the desired electrosurgical effect.The conmed laparoscopic electrosurgical blade series 60-5272 and 60-5274 are for use with the conmed universal plus series 60-6010 electrosurgical suction/irrigation device only.Do not attempt to connect these blades with any other electrosurgical connector, handle or instrument as serious patient injury may result.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 an unknown 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 ¿i don¿t have details about a second occurrence.The account contact only mentioned that he ¿had heard this happened before¿.I don¿t have a date, surgeon name, or type of procedure.However, i am under the impression that there was no significant burn/injury, no treatment of the burn or intervention necessary.¿ 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: 16906274
• MDR Text Key: 315359191
• Report Number: 1320894-2023-00086
• 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: 05/24/2023

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?: No
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic