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

Catalog Number	0845
Medical Device Problem Codes	Human-Device Interface Problem (2949); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 2/1/2024 photo analysis: this is an analysis of a set of images submitted for evaluation.Photos in the file are of two pads with serial numbers.Serial number that ends in (b)(6) is for file (b)(4).Serial number that ends in (b)(6) is for file (b)(4).An additional photo was provided.There were significant thermal injuries on both sides of the buttocks.The affected area of skin is bright red with small blisters on the left side.The out edges of redness area is uneven, with some small area unaffected.There was no skin breakdown visualized.The thermal injuries appeared to be second-degree burns, but the cause of the injuries could not be determined based on the photos.No conclusion could be reached as to how this issue occurred through photo analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Because the instrument was not returned our evaluation is limited.Additional information was requested, and the following was obtained: what medical intervention was used to treat the burn (such as ointment or stitches)? topical ointment indicated for skin burns was the problem reported at the pad site or at the alternative location? pillow site in addition to the burn, did the patient have any adverse consequences due to the problem? no are there any anticipated long-term effects of the burn or injury? no what is the patient's current condition? treated injury and full recovery of the site how long did the surgical procedure last? 6 hours what cleaning product or disinfectant (brand name or active ingredients) was used to clean the pad? not reported by the nurse was the pad washed with water and allowed to dry before this surgical procedure? not reported by the nurse is it possible that the patient came into contact with a metal portion of the or table? as reported by the nurse, no how was the room set up to include the patient and where was the pad in relation to the patient? the patient's preparation was carried out according to the operational standard, they placed the megasoft, thermal mattress, plastic, sheet, and sequence.Were there liquids used in the preparation? passage of a bladder catheter may have wetted the patient during surgery on (b)(6) 2021.In the surgery on (b)(6) 19th, the procedure involves extravasation of serum at the time of degermation and intra-operatively.What skin preparation regimen was used for the procedure? not reported by the nurse was urine or other fluids detected in the field after surgery? yes what generator was being used? not reported by the nurse what power levels was the generator at? not reported were there any diminished effects of the generator observed during surgery? not reported which monopolar disposables were used during the procedure? not reported how old is the patient? patient over 30 years old what is the patient's ethnicity? white on (b)(6)2023, patient underwent an arthroscopy/lca procedure with (b)(6) dr.And lasting 2:50 in the supine position.At the end of the procedure, a burn was observed in the coccyx region, evidenced by a red region characteristic of a first-degree burn.During the operation, a megadyne cautery plate and a thermal mattress with water heating at a temperature of 38º were used.The thermal mattress was superimposed on the megadyne cautery plate.This procedure involves extravasation of serum at the time of degermation and intra-operatively.According to reports, a burn injury to the cocix region, resulting in a first-degree burn injury.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.
Event or Problem Description
It was reported that during a arthroscopy a patient presented burns.The patient was submitted to arthroscopy/acl procedure lasting 2:50 in dorsal decubitus.At the end of the procedure was observed burn in the coccyx region evidenced by red region characteristic of first degree burn.In the transoperatory was used mergadyne cautery plate and thermal mattress with water heating with temperature of 38ºc the thermal mattress was overlaid the megadyne cautery plate.This procedure has extravasation of serum at the time of degermation and intraoperative.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/15/2024.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event, and is being considered not reportable.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/6/2024.

• Brand Name: MEGASOFT UNIVERSAL
• Common Device Name: MEGA SOFT UNIVERSAL
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; PR ; 3035526892
• MDR Report Key: 18621416
• Report Number: 1721194-2024-00011
• Device Sequence Number: 2369079
• Product Code: GEI
• UDI-Device Identifier: 10614559103906
• UDI-Public: 10614559103906
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K133726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2024
• Device Catalogue Number: 0845
• Device Lot Number: GS21017063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 02/01/2024; 02/15/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 02/06/2024; 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1998-2023
• Patient Sequence Number: 1
• Patient Sex: Unknown