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PERMA-HAND SA86GRecalls & reported problems

Ethicon, LLC · Black Braided Silk, Nonabsorbable Surgical Suture · Class 2 · Implant

Quick summary

This Ethicon Perma-Hand black silk suture has 119 adverse event reports, with 17 injuries and no deaths. Most describe the suture breaking during surgery, and some mention bleeding. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
120
Deaths reported
0
Injuries reported
17
Recalls naming it
0

Summary

The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 10705031050297), received between Sep 25, 2018 and Sep 23, 2026 — classified as 17 injuries, 103 malfunctions.

The most frequently reported specific device problem is “Break” (105 reports).

8 other recalls cover devices cleared under the same FDA submission (K946173); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 2 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 2 reportsJul 2024: 0 reportsAug 2024: 3 reportsSep 2024: 10 reportsOct 2024: 1 reportsNov 2024: 2 reportsDec 2024: 6 reportsJan 2025: 2 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 4 reportsJul 2025: 2 reportsAug 2025: 2 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 4 reportsDec 2025: 3 reportsJan 2026: 6 reportsFeb 2026: 3 reportsMar 2026: 2 reportsApr 2026: 5 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 2 reportsSep 2026: 1 reportsOct 2026: 0 reports20242025202610
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break105
  • Adverse Event Without Identified Device or Use Problem12
  • Material Separation2
  • Component Misassembled1
  • Delivered as Unsterile Product1
  • Device Contaminated During Manufacture or Shipping1

Patient problems

  • No Clinical Signs, Symptoms or Conditions75
  • Hemorrhage/Blood Loss/Bleeding17
  • No Consequences Or Impact To Patient8
  • Insufficient Information6
  • Erythema5
  • Not Applicable5
  • Inflammation4
  • Swelling/ Edema4

Recent adverse event reports

The 25 most recent of 120 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 23, 2026Break

    It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. At 11:00, the patient underwent surgery and the suture knot suddenly broke during hemostasis. Immediately replaced with new suture and successfully completed the sewing. There were no patient consequences reported. Additional information was requested.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50868963 ↗
  • MalfunctionAug 5, 2026Break

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 50147392 ↗
  • MalfunctionAug 5, 2026Break

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 50147384 ↗
  • MalfunctionApr 17, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HIGH LIGATION OF INGUINAL HERNIA PROCEDURE UNDER GENERAL ANESTHESIA ON (B)(6) 2026 AND SUTURE WAS USED. WHILE USING SUTURE TO TIE UP PATIENTS DURING LAPAROSCOPIC HIGH LIGATION, THE SUTURE SUDDENLY BROKE AND WAS IMMEDIATELY REPLACED. HOWEVER, THERE WAS ALSO A SITUATION OF BREAKAGE, AND THE MOBILE NURSE IMMEDIATELY OPENED THE NEW SUTURE WITHOUT ANY BREAKAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24916298 ↗
  • MalfunctionApr 17, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HIGH LIGATION OF INGUINAL HERNIA PROCEDURE UNDER GENERAL ANESTHESIA ON (B)(6) 2026 AND SUTURE WAS USED. WHILE USING SUTURE TO TIE UP PATIENTS DURING LAPAROSCOPIC HIGH LIGATION, THE SUTURE SUDDENLY BROKE AND WAS IMMEDIATELY REPLACED. HOWEVER, THERE WAS ALSO A SITUATION OF BREAKAGE, AND THE MOBILE NURSE IMMEDIATELY OPENED THE NEW SUTURE WITHOUT ANY BREAKAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24916291 ↗
  • InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT A DEBRIDEMENT AND SUTURING SURGERY ON (B)(6) 2026 AND SUTURE WAS USED ON THE PATIENT'S WOUND. THE PATIENT UNDERWENT THE PROCEDURE DUE TO TRAUMA. THE PATIENT EXPERIENCED POST-OP INFLAMMATION ON THE FOURTH DAY AFTER THE SURGERY, THE PATIENT COMPLAINED OF PAIN WHEN CHANGING DRESSING AT THE HOSPITAL. AFTER REMOVING THE GAUZE, THE DOCTOR FOUND THAT THERE WAS LEAKAGE OF SUTURES AT THE SUTURE SITE, AND THE WOUND WAS RED AND SWOLLEN. IODINE WET COMPRESS WAS GIVEN, AND THE SUTURE WAS REMOVED. THE PATIENT WAS ADVISED TO EXERCISE LESS AND ORALLY TAKE AMOXICILLIN CLAVULANATE POTASSIUM GRANULES FOR 3 DAYS. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Erythema; Fluid Discharge; Inflammation; Pocket Erosion; Swelling/ Edema

    MAUDE report 24873745 ↗
  • MalfunctionApr 11, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REMOVAL OF INTERNAL FIXATION DEVICE FOR RIGHT PATELLAR FRACTURE PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING AN INCISION FOR A PATIENT, THE SUTURE USED BY THE DOCTOR BROKE TWICE IN A ROW. THE DOCTOR IMMEDIATELY REPLACED THE SUTURE WITH A NEW ONE TO SUTURE THE INCISION FOR THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24847968 ↗
  • MalfunctionApr 1, 2026Material Separation

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON THE HAND ON (B)(6)2026 AND SUTURE WAS USED. THE PATIENT HAD CAME TO THE HOSPITAL FOR A WOUND DUE TO A HAND INJURY. DURING THE PROCEDURE, THE SURGEON DISINFECTED THE AFFECTED AREA AND PREPARED TO SUTURE THE WOUND. HOWEVER, IT WAS FOUND THAT THE SUTURE WAS LOOSELY WOVEN, SO THE SUTURE WAS REPLACED TO CONTINUE THE WOUND TREATMENT FOR THE PATIENT'S HAND INJURY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24757339 ↗
  • MalfunctionMar 12, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HIGH POSITION SUTURE OF HERNIA SAC PROCEDURE ON (B)(6) 2026, AND SUTURE WAS USED. DURING LAPAROSCOPIC HIGH POSITION SUTURE OF HERNIA SAC , THE SUTURE FREQUENTLY BROKE, AFFECTING THE SURGICAL PROCESS AND PROLONGING THE ANESTHESIA TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Insufficient Information

    MAUDE report 24586945 ↗
  • MalfunctionMar 12, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HIGH POSITION SUTURE OF HERNIA SAC PROCEDURE ON (B)(6) 2026, AND SUTURE WAS USED. DURING LAPAROSCOPIC HIGH POSITION SUTURE OF HERNIA SAC, THE SUTURE FREQUENTLY BROKE, AFFECTING THE SURGICAL PROCESS AND PROLONGING THE ANESTHESIA TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Insufficient Information

    MAUDE report 24583991 ↗
  • MalfunctionFeb 20, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THE SUTURE HAD WEAK TIE TENSILE STRENGTH WHEN KNOTTING WHICH IS EASY TO BREAK. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24405770 ↗
  • MalfunctionFeb 20, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THE SUTURE HAD WEAK TIE TENSILE STRENGTH WHEN KNOTTING WHICH IS EASY TO BREAK. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24405310 ↗
  • InjuryFeb 12, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, ON THE NINTH DAY AFTER SURGERY, DURING THE DRESSING CHANGE OF THE PATIENT'S ABDOMINAL INCISION, IT WAS FOUND THAT THE FIXATION SUTURE OF THE ABDOMINAL DRAINAGE TUBE HAD BROKEN FROM THE MIDDLE. IMMEDIATELY, A NEW STITCH WAS SUTURED AND THE DRAINAGE TUBE WAS REINFORCED, CAUSING THE PATIENT TO REQUIRE SECONDARY SUTURING. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Insufficient Information

    MAUDE report 24323496 ↗
  • MalfunctionJan 27, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE FREQUENTLY BROKE DURING THE OPERATION. AFTER CROCHET HOOKED THE SUTURE AND ENTERED THE ABDOMINAL CAVITY THROUGH THE SKIN, THE SUTURE BROKE AND COULD NOT BE SEWN. A TOTAL OF 5 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. IMMEDIATELY STOPPED AND REPLACED WITH OTHER TYPES OF SUTURE. IT AFFECTED THE SURGICAL PROCESS AND PROLONGED THE ANESTHESIA TIME. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24188008 ↗
  • MalfunctionJan 27, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE FREQUENTLY BROKE DURING THE OPERATION. AFTER CROCHET HOOKED THE SUTURE AND ENTERED THE ABDOMINAL CAVITY THROUGH THE SKIN, THE SUTURE BROKE AND COULD NOT BE SEWN. A TOTAL OF 5 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. IMMEDIATELY STOPPED AND REPLACED WITH OTHER TYPES OF SUTURES. IT AFFECTED THE SURGICAL PROCESS AND PROLONGED THE ANESTHESIA TIME. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24188005 ↗
  • MalfunctionJan 27, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE FREQUENTLY BROKE DURING THE OPERATION. AFTER CROCHET HOOKED THE SUTURE AND ENTERED THE ABDOMINAL CAVITY THROUGH THE SKIN, THE SUTURE BROKE AND COULD NOT BE SEWN. A TOTAL OF 5 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. IMMEDIATELY STOPPED AND REPLACED WITH OTHER TYPES OF SUTURES. IT AFFECTED THE SURGICAL PROCESS AND PROLONGED THE ANESTHESIA TIME. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24188003 ↗
  • MalfunctionJan 27, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE FREQUENTLY BROKE DURING THE OPERATION. AFTER CROCHET HOOKED THE SUTURE AND ENTERED THE ABDOMINAL CAVITY THROUGH THE SKIN, THE SUTURE BROKE AND COULD NOT BE SEWN. A TOTAL OF 5 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. IMMEDIATELY STOPPED AND REPLACED WITH OTHER TYPES OF SUTURE. IT AFFECTED THE SURGICAL PROCESS AND PROLONGED THE ANESTHESIA TIME. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24188001 ↗
  • MalfunctionJan 27, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE FREQUENTLY BROKE DURING THE OPERATION. AFTER CROCHET HOOKED THE SUTURE AND ENTERED THE ABDOMINAL CAVITY THROUGH THE SKIN, THE SUTURE BROKE AND COULD NOT BE SEWN. A TOTAL OF 5 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. IMMEDIATELY STOPPED AND REPLACED WITH OTHER TYPES OF SUTURE. IT AFFECTED THE SURGICAL PROCESS AND PROLONGED THE ANESTHESIA TIME. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24187999 ↗
  • MalfunctionJan 16, 2026Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT WAS ADMITTED DUE TO A REVERSIBLE MASS ON THE LEFT SIDE. AFTER COMPLETING RELEVANT EXAMINATIONS UPON ADMISSION, SURGICAL TREATMENT WAS REQUIRED. AT 3:30 PM, THE PHYSICIAN KNOTTED THE SUTURE WHILE SUTURING THE PATIENT'S WOUND. THE SUTURE SUDDENLY BROKE, AND WHEN KNOTTED AGAIN, THE SUTURE BROKE AGAIN. A NEW SUTURE WAS IMMEDIATELY REPLACED FOR SUTURING, AND THIS PHENOMENON DID NOT OCCUR AGAIN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED. ¿

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24095014 ↗
  • InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT UPPER AND LOWER LIP SURGERY ON (B)(6) 2025 DUE TO TRAUMA AND SUTURE WAS USED. AFTER ADMISSION, ROUTINE DISINFECTION AND TOWEL LAYING WERE PERFORMED, AND THE WOUND WAS WASHED WITH HYDROGEN PEROXIDE AND 0.9% SALINE SOLUTION TO REMOVE NECROTIC TISSUE AND FOREIGN OBJECTS. LOCAL ANESTHESIA WAS PERFORMED WITH 5ML LIDOCAINE INJECTION. AFTER ANESTHESIA, THE ORIGINAL SKIN WOUNDS OF THE UPPER AND LOWER LIPS WERE TAKEN, AND THE UPPER AND LOWER LIP WOUNDS WERE SUTURED LAYER BY LAYER WITH SUTURES. THE SUTURING WAS SUCCESSFUL, WITH A TOTAL OF 26 STITCHES. INTRAOPERATIVE BLEEDING OF 20 MILLILITERS, POSTOPERATIVE PATIENT SAFELY RETURNED TO THE WARD. ON THE 4TH DAY AFTER SURGERY, IT WAS FOUND THAT THE PATIENT HAD YELLOW LIQUID SECRETION OOZING OUT FROM 6 SUTURE ENDS, AND THERE WAS REDNESS AND INFLAMMATION AT THE SKIN CONTACT AREA OF THE SUTURE ENDS. IT WAS CONSIDERED THAT THE SUTURE END REACTION CAUSED INFECTION. THE DOCTOR IMMEDIATELY RINSED THE WOUND WITH 3% HYDROGEN PEROXIDE DISINFECTANT AND DISINFECTED IT WITH IODINE SOLUTION TWICE A DAY, INSTRUCTING THE PATIENT TO KEEP THE WOUND DRY. ON THE 7TH DAY AFTER SURGERY, IT WAS FOUND THAT THERE WAS STILL SECRET

    Patient problems: Erythema; Inflammation; Purulent Discharge

    MAUDE report 23848316 ↗
  • MalfunctionDec 12, 2025Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23791092 ↗
  • MalfunctionDec 4, 2025Device Contaminated During Manufacture or Shipping; Component Misassembled; Device Contaminated During Manufacture or Shipping; Component Misassembled

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE DOCTOR DISCOVERED MIXED SUTURE INSIDE THE PRODUCT BEFORE USING IT. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23714921 ↗
  • InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED TO SEW SUBCUTANEOUSLY. POST-OP, THE PATIENT EXPERIENCED SUTURE EXTRUSION AND INFECTION. AROUND 1 WEEK AFTER THE SURGERY, THE WOUND WAS FOUND WITH SUTURE EXTRUSION, REDNESS AND ABSCESS. DEBRIDEMENT WAS DONE, THE PATIENT IS CURRENTLY STABLE. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Abscess; Erythema; Pain; Pocket Erosion; Swelling/ Edema; Unspecified Infection

    MAUDE report 23533591 ↗
  • MalfunctionNov 6, 2025Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT A WHOLE UTERUS AND BILATERAL SALPINGECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE DOCTOR USED SUTURE TO SUTURE THE SURGICAL INCISION AND FIX THE TISSUE DURING THE OPERATION. WHEN USING THE SUTURE TO SUTURE THE WOUND, THE SUTURE WAS PULLED MULTIPLE TIMES AND IMMEDIATELY BROKE, CAUSING THE SUTURE TO FAIL. THE DOCTOR IMMEDIATELY REPLACED THE SUTURE AND RE SUTURED IT, WHICH RESULTED IN PROLONGED SURGERY TIME AND MULTIPLE SKIN PUNCTURES. PATIENTS MAY HAVE AN INCREASED RISK OF INFECTION OR ANESTHESIA RELATED COMPLICATIONS DUE TO PROLONGED SURGICAL TIME. POSTOPERATIVE INCISION MONITORING HAS BEEN STRENGTHENED TO PREVENT INFECTION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Insufficient Information

    MAUDE report 23490593 ↗
  • MalfunctionNov 4, 2025Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY UNDER GENERAL ANESTHESIA SURGERY AT 15:55. DURING THE SURGERY, THE DOCTOR NEEDED TO USE SUTURE TO FIX THE DRAINAGE TUBE, BUT THE SUTURE BROKE MULTIPLE TIMES AND COULD NOT BE USED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23463938 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K946173. One submission often covers many models, so check the product and lot details in each record.

  • Z-1516-2025 · Mar 7, 2025 · Open, Classified
    ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
  • Z-1097-2025 · Dec 20, 2024 · Open, Classified
    PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovas
  • Z-2486-2020 · Jun 10, 2020 · Open, Classified
    PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870
  • Z-1841-2019 · Apr 19, 2019 · Terminated
    ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue app
  • Z-1842-2019 · Apr 19, 2019 · Terminated
    ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue appr
  • Z-0747-2019 · Dec 18, 2018 · Terminated
    PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approxima
  • Z-1839-2015 · May 8, 2015 · Terminated
    Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast ab
  • Z-0492-2015 · Oct 17, 2014 · Terminated
    Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.

Other SUTURE, NONABSORBABLE, SILK devices

All SUTURE, NONABSORBABLE, SILK devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.