MAUDE Adverse Event Report: CONMED UTICA 20/CA ULTRA NONSTICK 10FT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number PLPUL2020

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 03/15/2024

Event Type  malfunction  

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.

Event Description

A sales representative reported on behalf of a customer that the plpul2020, 20/ca ultra nonstick 10ft device was being used during a colorectal surgery on (b)(6) 2024, and ¿surgeon describes incident where after changing to guarded tip (covidien edge insulated blade electrode 2.75" e1455) he touched the blade (while it was not activated) and it burnt through 2 layers of gloves and caused a minor burn on his finger.He also commented that it was possible that the tissue appeared to be hotter than usual (not sure how he determined this).Machine was set to 30:30 at the time of incident.Small burn to surgeon finger but no extra treatment was sought, surgeon changed gloves and completed procedure.¿.Through follow-up assessment, the customer indicated that there were ¿no long term effects apart from puncturing the gloves requiring a replacement set of gloves.They completed the procedure with covidien blade and did not report any other issues as far as i know." there was a delay of 2 minutes.There was no report of long-lasting injury, medical/surgical intervention, or extended hospitalization for the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Have been updated to reflect correct manufacturer name and contact information.Received thirteen plpul2020 in original package.Lot number was verified.Performed a visual inspection, no abnormalities or defects were confirmed.Performed a functional inspection using the esu system 7550 (c8406), the device functioned as intended with no palpable heat within the tip of 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 shows a total of 13 devices for this lot number and failure mode; however, they were not confirmed.A two-year review of complaint history revealed there has been a total of 20 reports, regarding 32 devices, for this device family and failure mode.During this same time frame 4,455,910 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 0.000007.Per the instructions for use, the user is advised the following: the electrode tip may remain hot enough to cause burns after the current has been de-activated.When not in use, the active electrode should be placed in a clean, dry, non-conductive safety holster.Inadvertent contact with the patient may result in burns.The electrosurgical generator¿s intensity should be set as low as is necessary to achieve the desired effect.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

A sales representative reported on behalf of a customer that the plpul2020, 20/ca ultra nonstick 10ft device was being used during a colorectal surgery on (b)(6) 2024, and ¿surgeon describes incident where after changing to guarded tip (covidien edge insulated blade electrode 2.75" e1455) he touched the blade (while it was not activated) and it burnt through 2 layers of gloves and caused a minor burn on his finger.He also commented that it was possbile that the tissue appeared to be hotter than usual (not sure how he determined this).Machine was set to 30:30 at the time of incident.Small burn to surgeon finger but no extra treatment was sought, surgeon changed gloves and completed procedure.¿.Through follow-up assessment, the customer indicated that there were ¿no long term effects apart from puncturing the gloves requiring a replacement set of gloves.They completed the procedure with covidien blade blade and did not report any other issues as far as i know." there was a delay of 2 minutes.There was no report of long-lasting injury, medical/surgical intervention, or extended hospitalization for the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 20/CA ULTRA NONSTICK 10FT
• 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 19086888
• MDR Text Key: 340601782
• Report Number: 1320894-2024-00099
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 20845854061210
• UDI-Public: (01)20845854061210(17)261020(10)WM20231055
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K230547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PLPUL2020
• Device Lot Number: WM20231055
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic