MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY, LLC UNKNOWN MAE GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number MAE UNK GEN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Necrosis (1971); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Abstract: post-bariatric patients undergoing abdominoplasty have a relatively high risk of complications due to residual obesity and major comorbidities.Also, conventional electrosurgery and the associated thermal tissue damage may compromise outcomes.This retrospective randomised clinical study evaluated the effect of low-thermal plasma dissection device (peak [pulsed electron avalanche knife] plasma blade) in comparison with conventional electrosurgery.A total of 52 post-bariatric patients undergoing abdominoplasty were randomised to peak plasmablade (n = 26) and to monopolar electrosurgery (n = 26).Wounds of 20 patients per group were examined histologically for acute thermal injury depth.In peak plasmablade incisions, acute thermal damage was significantly reduced compared with standard of care (40% vs 75%; p =.035).Also, acute thermal injury depth from peak plasmablade was less than that from electrosurgery (2780 ¿m vs 4090 ¿m).Significantly less total complication rate (30.8% vs 69.2%; p =.012) was found by peak plasmablade compared with electrosurgery.Moreover, the peak plasmablade showed less than half as many wound healing problems (19.2% vs 46.2%; p =.075), far fewer secondary bleeding (7.7% vs 30.8%; p =.075), and no seroma compared with four seroma with the standard of care (0% vs 15.4%; p =.11).Peak plasmablade appears to be superior to traditional monopolar electrosurgery for post-bariatric abdominoplasty, because it demonstrated significantly less tissue damage, less total complication rate, and fewer postoperative seroma resulting in faster wound healing.Methods: a retrospective study was performed with data of 52 patients who had undergone post-bariatric abdominoplasties from january 2017 to december 2018.In 26 patients, skin incision and preparation were conducted with peak plasmablade.In another 26 patients, skin incision, incision of subcutaneous tissue, and preparation until fascia were performed with conventional monopolar electrosurgical device several parameters were determined such as age, body mass index (bmi), weight of resection, operative time, time until drain removal, daily and total volume of drain output, postoperative pain, complications, and revisions.Wound healing problems included dehiscence, infection and necrosis.Number of drains: peak plasmablade 2.6 ± 0.6, conventional monopolar electrosurgery 2.8 ± 0.5.Drain output of 1 postoperative day (ml): peak plasmablade 121.8 ±88.4, conventional monopolar electrosurgery 144.4 ± 97.9.Total drain output (ml): peak plasmablade 593.6 ± 619.1, conventional monopolar electrosurgery 847.7 ± 960.4.Time until drain removal (days): peak plasmablade 7.8 ± 6.9, conventional monopolar electrosurgery 8.0 ± 5.4.Pain at 1 postoperative day: peak plasmablade 1.2 ± 4.1, conventional monopolar electrosurgery 1.6 ± 1.5, operative time (min): peak plasmablade 137.8 ± 39.4, conventional monopolar electrosurgery 128.8 ± 47.6 in-patient stay (days): peak plasmablade 5.6 ± 4.1, conventional monopolar electrosurgery 6.6 ± 3.5.Haemoglobin preoperative (g/dl): peak plasmablade 13.29 ± 1.58, conventional monopolar electrosurgery 13.68 ± 13.68 ± 1.58.The adjustments used in post-bariatric surgery are as follows: electrosurgery: erbe vio-hf-surgery system; cut: auto cut/classic coag (forced coag: effect 2, maximum 80 w; dry cut: effect 4, maximum 180 w); bipolar: bipolar soft coag plasmablade (pulsar ii): cut: 5-6, coag: 7 preserved specimens of resection were harvested from 20 patients of each group (40 specimens) and immersed in 10% neutral-buffered formalin for a minimum of 24 hours and then embedded in paraffin for histologic analysis of acute thermal injury depth.All specimens were evaluated using microscopic measurements by a single pathologist blinded to plasmablade.Analysis: total complications: peak plasmablade 8 (30%), conventional monopolar electrosurgery 18 (69.2%) minor (local) complications: peak plasmablade 5 (19.2%), conventional monopolar electrosurgery 18 (69.2%) major complications (revision required): peak plasmablade 3 (11.5%), conventional monopolar electrosurgery 0; wound healing problems 2 (66.7%); umbilical loss 1 (33.3%) seroma: peak plasmablade 0, conventional monopolar electrosurgery 4 (15.4%) secondary bleeding: peak plasmablade 2 (7.7%), conventional monopolar electrosurgery 8 (30.8%) wound healing problems (wound dehiscence, infection, necrosis): peak plasmablade 5 (19.2%), conventional monopolar electrosurgery 12 (46.2%) thermal tissue injury: peak plasmablade 8 (40%), conventional monopolar electrosurgery 15 (75%) mean thermal injury depth: peak plasmablade 2780 um, conventional monopolar electrosurgery 4090 um.Acute thermal damage: peak plasmablade 8 (40%), conventional electrosurgery 15 (75%).

• Brand Name: UNKNOWN MAE GENERATOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY, LLC; 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): MEDTRONIC ADVANCED ENERGY, LLC; 180 international drive; portsmouth NH 03801
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9641610
• MDR Text Key: 190383532
• Report Number: 1226420-2020-00013
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAE UNK GEN
• Device Catalogue Number: MAE UNK GEN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention