MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGASOFT UNIVERSAL DUAL; MEGA SOFT UNIVERSAL DUAL

Model Number 0846

Device Problems Electromagnetic Interference (1194); Arcing of Electrodes (2289)

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

Event Date 08/08/2022

Event Type  malfunction  

Event Description

It was reported that during the chole procedure, the doctor experienced an arcing events with the monopolar instrument.The bovie settings were turned up from three to five because the surgeon didn¿t feel she was getting enough power, coag effect.They switched from mega soft pad to sticky pad, it resolved the issue.There were no patient consequences.

Manufacturer Narrative

(b)(4) investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.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.Additional information received: viodv generator for robotic procedures were used.There was a pink pad between the megasoft and the patient.Power setting was at 5.(vs.Power effect): system was in coag mode.Power setting was turned back down to 3 with sticky pad.Also, there was electro-lube used on the scissors when placing the tip-head cover.Tech says surgeon was using the scissors at time of the incident, and the camera and scissors were next to each other.Another tech in the room claims there was no ¿arcing", he said it was an inaccurate description of what actually occurred.He said that ¿because the pad wasn¿t grounding properly, the energy took the path of least resistance and went up the scope, causing a scramble of the monitor, which disrupted visibility to the surgical site.There were no sparks, or visible current.¿ 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.

• Brand Name: MEGASOFT UNIVERSAL DUAL
• Type of Device: MEGA SOFT UNIVERSAL DUAL
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 329348013
• MDR Report Key: 15300304
• MDR Text Key: 302166502
• Report Number: 1721194-2022-00072
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559104248
• UDI-Public: 10614559104248
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2022

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: 0846
• Device Catalogue Number: 0846
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1