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

Catalog Number PLPUL2020

Device Problem Material Fragmentation (1261)

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

Event Date 02/26/2024

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 an unnamed procedure on (b)(6) 2024, and ¿prepackaged electrode changed out for ethicon coated tip.Casing that houses electrode broke off.Surgical tech denied forcing electrode.Denied poor seating of electrode.Plastic piece of casing remained in the capture port of ultra, did not enter patient.Patient was not harmed.Plpul2020 was removed from sterile field and any broken pieces confirmed also removed confirmed all parts by [staff].Per staff involved this has happened one other time at sky ridge.Similar scenario.Unable to provide additional details.¿ the procedure was completed with an alternate same device and with no reported delay.There was no report of injury, medical surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.A two-year lot history review cannot be conducted as a lot number was not provided.A device history record (dhr) review cannot be conducted as a lot number was not provided.A two-year review of complaint history revealed there has been a total of 42 reports, regarding 65 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).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 an unnamed procedure on (b)(6) 2024, and ¿prepackaged electrode changed out for ethicon coated tip.Casing that houses electrode broke off.Surgical tech denied forcing electrode.Denied poor seating of electrode.Plastic piece of casing remained in the capture port of ultra, did not enter patient.Patient was not harmed.Plpul2020 was removed from sterile field and any broken pieces confirmed also removed/ confirmed all parts by [staff].Per staff involved this has happened one other time at sky ridge.Similar scenario.Unable to provide additional details.¿.The procedure was completed with an alternate same device and with no reported delay.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.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): WICKIMED; 4-5/f, building b; tangjiao industrial area; lilin, huizhou, prc 51600 0; CH 516000
• Manufacturer (Section G): WICKIMED; 4-5/f, building b; tangjiao industrial area; lilin, huizhou, prc 51600 0; CH 516000
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 18865272
• MDR Text Key: 337568691
• Report Number: 1320894-2024-00058
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K230547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic