BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 6289847 · Received January 31, 2017

    Report

    Report Number
    1219930-2017-00122
    Event Type
    Injury
    Date Received
    January 31, 2017
    Report Date
    January 4, 2017
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    KOHLER G., SMALL BOWEL OBSTRUCTION AFTER TAPP REPAIR CAUSED BY A SELF-ANCHORING BARBED SUTURE DEVICE FOR PERITONEAL CLOSURE: CASE REPORT AND REVIEW OF THE LITERATURE. HERNIA: THE JOURNAL OF HERNIAS AND ABDOMINAL WALL SURGERY [HERNIA] 2015 JUN; VOL. 19 (3), PP. 389-94. DATE OF ELECTRONIC PUBLICATION: 2014 AUG 12. DOI:10.1007/S10029-014-1301-1. (B)(4). ADDITIONAL ATTEMPTS TO OBTAIN INFORMATION AND THE DEVICE HAVE BEEN MADE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH NEW DETAILS IF THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: FROM STUDYING LITERATURE I HAVE SEEN THAT THE USAGE OF V-LOCK SUTURE IN ABDOMINAL AT TAPP SURGERIES LEAD TO INTESTINAL OBSTRUCTION (3 INCIDENTS DESCRIBED IN LITERATURE). ALSO THERE ARE ALSO AFTER GYNECOLOGICAL SURGERY AN REPORTED INCIDENT WHICH IS AT COURT KNOWN. KOHLER G., SMALL BOWEL OBSTRUCTION AFTER TAPP REPAIR CAUSED BY A SELF-ANCHORING BARBED SUTURE DEVICE FOR PERITONEAL CLOSURE: CASE REPORT AND REVIEW OF THE LITERATURE. HERNIA: THE JOURNAL OF HERNIAS AND ABDOMINAL WALL SURGERY [HERNIA] 2015 JUN; VOL. 19 (3), PP. 389-94. DATE OF ELECTRONIC PUBLICATION: 2014 AUG 12. DOI:10.1007/S10029-014-1301-1. AN (B)(6) MALE WITH A BODY-MASS INDEX OF (B)(6) PRESENTED WITH A SYMPTOMATIC BILATERAL INGUINAL HERNIA. WE SUGGESTED LAPAROSCOPIC INGUINAL HERNIA REPAIR AND A BILATERAL TAPP WAS PERFORMED BY AN EXPERIENCED CONSULTANT SURGEON (NONE OF THE AUTHORS) OF THE DEPARTMENT OF GENERAL AND VISCERAL SURGERY, SISTERS OF CHARITY HOSPITAL, LINZ. THE ABDOMINAL PRESSURE WAS REDUCED TO 8 MM ALLOWING A TENSION-FREE PERITONEAL CLOSURE WITH A RUNNING SUTURE BY USING A POLYGLYCONATE UNIDIRECTIONAL SELF-ANCHORING KNOTLESS, ABSORBABLE WOUND CLOSURE DEVICE (COVIDIEN, V-LOC 180_). THE PATIENT HAD AN UNEVENTFUL POSTOPERATIVE COURSE AND WAS DISCHARGED HOME ON DAY THREE AFTER SURGERY. HE RETURNED ON POSTOPERATIVE DAY 13 WITH INCREASING ABDOMINAL PAIN AND VOMITING. PHYSICAL EXAM REVEALED A HYPERTYMPANIC, TENDER, AND DISTENDED ABDOMEN. PLAIN ABDOMINAL VIEWS SHOWED AN ILEUS PATTERN AND SONOGRAPHICAL EXAMINATION OF THE ABDOMEN SHOWED A "PIANO KEY PHENOMENON" OF THE SMALL BOWEL WITH PENDULAR PERISTALTIC AND INTRAPERITONEAL FLUIDNESS. THE CAUSE OF THE ILEUS WAS THE RIGHTSIDED BARBED SUTURE MATERIAL FOR PERITONEAL CLOSURE, WHICH WAS INGROWING INTO THE SMALL BOWEL SEROUS MEMBRANE THAT LED TO SEVERE TENSION AND COMPLETE OBSTRUCTION ABOUT 30 CM APART FROM THE VALVULA COLI. IT WAS NOT DOCUMENTED IN THE OPERATIVE REPORT OF THE INITIAL PROCEDURE THAT THE ENTIRE THREAD WAS ENGULFED AND COVERED BY TISSUE AT THE END OF THE FIRST OPERATION, BUT THE OPERATING SURGEON ASSURED A PROPER USAGE. THE DEVICE HAD OBVIOUSLY CUT THROUGH THE PERITONEUM BESIDE THE CLOSED DEFECT WHEREBY A FREE PIECE OF THE THREAD BECAME EXPOSED INTRAPERITONEALLY. CERTAINLY, THE SUTURE ITSELF CAUSED THE PROBLEM BECAUSE THE BARBS WERE INSEPARABLE INGROWN INTO THE SMALL BOWEL. NO BOWEL RESECTION WAS REQUIRED, BUT THE SUTURE MATERIAL HAD TO BE CUT OUT OF THE INTESTINAL WALL. THIS COULD BE PERFORMED WITHOUT FULL THICKNESS ENTEROTOMY. THE SEROSAL AND MUSCULAR DEFECT WAS CLOSED WITH ABSORBABLE SINGLE-KNOT SUTURES. ALL THE SELF-ANCHORING SURGICAL SUTURE MATERIAL WAS EXPLANTED FROM BOTH PERITONEAL INCISIONS AND THE PERITONEUM WAS AGAIN CLOSED WITH ABSORBABLE MONOFILAMENT RUNNING SUTURES AND ABSORBABLE CLIP FIXATION (ETHICON, (B)(4)) WITHOUT MESH REMOVAL. THE PATIENT HAD AN UNEVENTFUL POSTOPERATIVE COURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72988 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM COVIDIEN, FORMERLY US SURGICAL A DIVISON UNKNOWN-VLOC

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention