BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC

    MDR report key: 25201692 · Received May 18, 2026

    Report

    Report Number
    3005075853-2026-03712
    Event Type
    Injury
    Date Received
    May 18, 2026
    Date of Event
    September 2, 2025
    Report Date
    May 18, 2026
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 5/18/2026. B3: PUBLICATION YEAR OF 2025. D4: BATCH#: UNK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. 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. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: PAJAANTI S, ORANGES CM, DI SUMMA PG, GIORDANO S. IS ANTIBIOTIC PROPHYLAXIS NECESSARY IN MASTECTOMY WITH ANTIMICROBIAL SUTURES? A COMPARATIVE ANALYSIS. CANCERS (BASEL). 2025 SEP 2;17(17):2892. DOI: 10.3390/CANCERS17172892. PMID: 40940989; PMCID: PMC12427672. THE AIM OF THIS STUDY IS TO EVALUATE THE EFFECT OF TC-COATED SUTURE MATERIAL, WITH OR WITHOUT ANTIBIOTIC PROPHYLAXIS, IN MASTECTOMY PROCEDURES. BETWEEN 2015¿2017, A TOTAL OF 300 PATIENTS WITH OPERABLE MALIGNANT BREAST CANCER WHO UNDERWENT MASTECTOMY. PATIENTS WERE DIVIDED INTO TWO GROUPS: PATIENTS RECEIVING TC-COATED SUTURES AND ANTIBIOTIC PROPHYLAXIS (N=155) AND PATIENTS RECEIVING TC-COATED SUTURES ALONE (N=145). WOUND CLOSURE EMPLOYED A TWO-LAYER SUTURE TECHNIQUE: TC-COATED POLYGLACTIN 910 SUTURES (VICRYL PLUS¿, ETHICON INC., SOMERVILLE, NJ, USA) WERE USED FOR THE DERMAL LAYER, AND INTRACUTANEOUS CLOSURE WAS ACHIEVED WITH THE V-LOC¿ 90 ABSORBABLE WOUND CLOSURE DEVICE (MEDTRONIC, MANSFIELD, MA, USA) AND HARMONIC FOCUSTM(ETHICON, INC., SOMERVILLE, NJ, USA). REPORTED COMPLICATIONS ARE CLAVIEN¿DINDO GRADE I N=50; SUPERFICIAL INFECTION N=21; WOUND DEHISCENCE TREATMENT: NOT MENTIONED CLAVIEN¿DINDO GRADE II N=213; SEROMA TREATMENT: PERCUTANEOUS ASPIRATION OR SURGICAL DRAINAGE N=24; DEEP INFECTION TREATMENT: NOT MENTIONED CLAVIEN¿DINDOGRADE IIIA N=4; SKIN NECROSIS N=9; WOUND DEHISCENCE TREATMENT: NOT MENTIONED CLAVIEN¿DINDO GRADE IIIB N=7; HEMATOMA TREATMENT: PERCUTANEOUS ASPIRATION OR SURGICAL DRAINAGE IN CONCLUSION, THE ADDITION OF PROPHYLACTIC ANTIBIOTIC ADMINISTRATION TO TC-COATED SUTURES DID NOT SIGNIFICANTLY REDUCE THE INCIDENCE OF SURGICAL SITE INFECTIONS FOLLOWING MASTECTOMY FOR BREAST CANCER. DESPITE THE HIGHER RATES OF SMOKING AND OBESITY IN THE PROPHYLAXIS GROUP, WHICH ARE ESTABLISHED RISK FACTORS FOR INFECTION, OUR FINDINGS SUGGEST THAT THESE INTERVENTIONS MAY NOT OFFER ADDITIONAL BENEFITS IN THIS PATIENT COHORT. WHILE THE RESULTS SUGGEST NO SIGNIFICANT BENEFIT OF PROPHYLACTIC ANTIBIOTICS IN THIS CONTEXT, A COMPREHENSIVE SSI PREVENTION BUNDLE IS LIKELY REQUIRED, AND THE FINDINGS SHOULD BE INTERPRETED WITH CAUTION DUE TO THE STUDY¿S LIMITED POWER. LARGER, WELL-POWERED STUDIES ARE NEEDED TO MORE DEFINITIVELY ASSESS THE ROLE OF PROPHYLACTIC ANTIBIOTICS IN PREVENTING SSIS FOLLOWING MASTECTOMY WHEN ANTIMICROBIAL SUTURES ARE USED. INSTEAD, OPERATIVE TIME AND HEMATOMA FORMATION WERE IDENTIFIED AS THE STRONGEST PREDICTORS OF INFECTION. OUR FINDINGS ALSO SUGGEST THAT EFFORTS TO OPTIMIZE SURGICAL EFFICIENCY AND HEMOSTASIS MAY BE MORE IMPACTFUL THAN ROUTINE SAP USE IN REDUCING POSTOPERATIVE INFECTIONS. GIVEN THE POTENTIAL RISKS ASSOCIATED WITH OVERUSE OF ANTIBIOTICS AND ANTIMICROBIAL RESISTANCE, FURTHER RESEARCH IS NECESSARY TO DETERMINE THE MOST EFFECTIVE STRATEGIES TO REDUCE SSIS AND IMPROVE POSTOPERATIVE OUTCOMES IN BREAST CANCER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383907 HARMONIC INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention