MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. ZIP PENCIL 10FT W/0012 ECONN; ZIP PEN SMOKE EVAC PNCL E-Z CLEAN 22MM

Model Number 252510EC

Device Problem Arcing of Electrodes (2289)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure there was arcing of the electrodes.No additional information was provided.There was no patient problem no clinical signs, symptoms or conditions.

Manufacturer Narrative

(b)(4).Date of event: (b)(6) 2022.Maude report number: 1721194-2022-00058.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: could you please provide the country of origin.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 2/14/2024 this event was previously reported under 1721194-2022-00058.

• Brand Name: ZIP PENCIL 10FT W/0012 ECONN
• Type of Device: ZIP PEN SMOKE EVAC PNCL E-Z CLEAN 22MM
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): NEW DEANTRONICS TAIWAN, LTD.
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 329348013
• MDR Report Key: 15461680
• MDR Text Key: 302167086
• Report Number: 1721194-2022-00086
• Device Sequence Number: 1
• Product Code: FYD
• UDI-Device Identifier: 10614559105344
• UDI-Public: 10614559105344
• Combination Product (y/n): N
• PMA/PMN Number: K141587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

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
• Device Operator: Health Professional
• Device Model Number: 252510EC
• Device Catalogue Number: 252510EC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/04/2022
• Initial Date FDA Received: 09/21/2022
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1