Surgipro ll SP-5682Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521036871), received between Jan 3, 2018 and Apr 10, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Break” (11 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A THYROHYOID LESION EXCISION UNDER GENERAL ANESTHESIA, WHILE BEING USED FOR SKIN CLOSURE, A NEEDLE¿SUTURE SEPARATION OCCURRED. THE SUTURE WAS REPLACED WITH ANOTHER ONE, WHICH FUNCTIONED NORMALLY. THE ISSUE CAUSED LOCAL SKIN DAMAGE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24841615 ↗
• MalfunctionJul 15, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN UMBILICAL HERNIA PROCEDURE, AFTER PASSING THE FIRST POINT OF THE SUTURE WHILE SUTURING THE SKIN, THE THREAD BROKE IN THE MIDDLE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19745221 ↗
• MalfunctionApr 11, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, AT THE TIME OF SKIN CLOSURE, THE THREAD BROKE ON THREE NON-ABSORBABLE SUTURES. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093067 ↗
• MalfunctionApr 11, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, AT THE TIME OF SKIN CLOSURE, THE THREAD BROKE ON THREE NON-ABSORBABLE SUTURES. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093042 ↗
• MalfunctionApr 11, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, AT THE TIME OF SKIN CLOSURE, THE THREAD BROKE ON THREE NON-ABSORBABLE SUTURES. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19092995 ↗
• InjuryMay 7, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST OPERATIVELY, ON A SURGICAL REPAIR OF A RUPTURED ANTERIOR TIBIALIS, THE PATIENT, SUSTAINED A DISRUPTION OF TRAUMATIC INJURY WOUND REPAIR DUE TO DISSOLVABLE SUTURES THAT FAILED TO DISSOLVE LEADING TO AN INFECTION. THE PATIENT REQUIRED NUMEROUS OUT PATIENT VISITS WITH WOUND THERAPY DEPARTMENT DUE TO THE STITCHES FAILING TO ABSORB. WHEN WOUND CARE EXPLORED THE WOUND TO DETERMINE THE DEPTH, THEY LOCATED THESE SUTURES WERE STILL IN THE WOUND BED, UNDISSOLVED. THE PATIENT HAD TO HAVE A PERIPHERALLY INSERTED CENTRAL CATHETER LINE (PICC) PLACED AND GIVEN INTRAVENOUS VANCOMYCIN AS OUTPATIENT AND THEN TRANSITIONED TO ORAL CLINDAMYCIN. THE PATIENT HAD TO HAVE A WOUND VACUUM ASSISTED CLOSURE (VAC) PLACED AS WELL TO HELP MANAGE DRAINAGE FROM THIS SITE. THE PATIENT WAS ON ORAL AND INTRAVENOUS ANTIBIOTICS FOR SEVERAL MONTHS AND REQUIRED ADVANCED WOUND DRESSINGS, AS WELL AS, PERIODIC CONSERVATIVE SHARP DEBRIDEMENT. THE SURGICAL WOUND DEHISCED, EXPOSING THE ANTERIOR TIBIALIS TENDON AND SURROUNDING SOFT TISSUE. IMPAIRMENT INCLUDED LOSS OF ANKLE MOBILITY AND STRENGTH. THE SOFT TISSUE COVERING THE SURFACE OF THE FOOT AND ANTERIOR ANKLE WAS RELATIVELY THIN PARTICULARLY IN

  Patient problems: Ambulation or Postural Difficulties; Impaired Healing; Injury; No Code Available; Pain; Post Operative Wound Infection; Tissue Damage; Wound Dehiscence

  MAUDE report 10032831 ↗
• MalfunctionOct 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPEN ULNA ASSEMBLY, AT SKIN CLOSURE, THE NEEDLE SEPARATED FROM THE THREAD. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9209736 ↗
• MalfunctionOct 18, 2019Break; Break

  ACCORDING TO THE REPORTER, ON A REDUCTION MAMMOPLASTY PROCEDURE, DURING THE PASSAGE OF THE DEVICE THROUGH THE TISSUE, THE NEEDLE AND THREAD BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9209732 ↗
• MalfunctionSep 9, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY, IN THE MOMENT OF KNOTTING, THE THREAD BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8976569 ↗
• MalfunctionJul 28, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN VIA PELVIC RADICAL LYMPHADENECTOMY PROCEDURE, WHILE CLOSING THE PORT OF LAPAROSCOPY, THE THREAD BROKE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8834694 ↗
• MalfunctionJul 23, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING PLASTIC SURGERY, THE SUTURE BREAKS IN THE MANIPULATION WITH THE NEEDLE HOLDER. IT COULD INFLUENCE IN THE PROCESS OF CICATRIZATION INCREASING THE RISK OF DISCRIMINATION BY MALACALITY, LOSING THE TENSION OF THE SAME. THE CASE WAS COMPLETED BY USING OTHER UNIT OF SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8817604 ↗
• MalfunctionFeb 12, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN PROCEDURE FOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INSERTION, AT THE VERY END WHEN THEY WERE CLOSING THE SKIN, THE SUTURE BROKE WHILE PERFORMING THE 'FLOSSING' TECHNIQUE. THE PHYSICIAN OPENED ANOTHER STRAND AND COMPLETED THE CLOSURE. THE PATIENT'S HOSPITAL STAY WAS EXTENDED ONE NIGHT FOR OBSERVATION PURPOSES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8332548 ↗
• MalfunctionMar 21, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, THE FIRST DEVICE'S NEEDLE AND THREAD WAS FOUND BROKE BEFORE IT WAS USED. THE SECOND DEVICE'S THREAD WAS BROKEN AFTER OPENING THE PACK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7357256 ↗
• MalfunctionJan 3, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC OPEN SURGERY, IN THE FIRST STITCH, THE THREAD BROKE. THEY USED ANOTHER SUTURE TO COMPLETE THE CASE. THERE IS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7160962 ↗