Surgidac 170041Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20884521127002), received between Apr 10, 2018 and Jun 27, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K934738); 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHILE CLOSING THE VAGINAL CUFF, THE NEEDLE BROKE IN HALF AND FELL INTO THE PATIENT'S CAVITY. THE SURGEON WAS ABLE TO RETRIEVED HALF OF THE NEEDLE, BUT THE OTHER HALF REMAINED IN THE PATIENT. SEARCHING FOR THE BROKEN NEEDLES LED TO 30 MINUTES OR MORE EXTENDED SURGICAL TIME. THE FOLLOWING DAY, X-RAY WAS PERFORMED TO LOCATE THE OTHER PIECE. IT WAS NOTED THAT THERE WILL BE ADDITIONAL OPERATION TO RETRIEVE THE OTHER HALF OF THE NEEDLE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 19625880 ↗
• MalfunctionJun 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC DIAGNOSTIC THORACOSCOPIC IMAGE PLICADURA PROCEDURE, AT THE TIME OF MAKING A KNOT WHILE REPAIRING THE DIAPHRAGM, THE NEEDLE DETACHED FROM THE THREAD WHEN THE SURGEON TRIED PULLING THE SUTURE TO CHECK FOR BREAKAGE AFTER FINISHING THE CX. THE ISSUE OCCURRED IN THREE SUTURES FROM THE SAME VIAL. THE SURGEON DID NOT TRUST THE KNOTS AND OPTED TO START FROM SCRATCH USING A COMPETITOR'S SUTURE TO RESOLVE THE ISSUE. THIS LED TO 30 MINUTES OR MORE EXTENDED SURGICAL TIME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19445179 ↗
• MalfunctionJun 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC DIAGNOSTIC THORACOSCOPIC IMAGE PLICADURA PROCEDURE, AT THE TIME OF MAKING A KNOT WHILE REPAIRING THE DIAPHRAGM, THE NEEDLE DETACHED FROM THE THREAD WHEN THE SURGEON TRIED PULLING THE SUTURE TO CHECK FOR BREAKAGE AFTER FINISHING THE CX (SURGERY). THE ISSUE OCCURRED IN THREE SUTURES FROM THE SAME VIAL. THE SURGEON DID NOT TRUST THE KNOTS AND OPTED TO START FROM SCRATCH USING A COMPETITOR'S SUTURE TO RESOLVE THE ISSUE. THIS LED TO 30 MINUTES OR MORE EXTENDED SURGICAL TIME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19445177 ↗
• MalfunctionJun 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC DIAGNOSTIC THORACOSCOPIC IMAGE PLICADURA PROCEDURE, AT THE TIME OF MAKING A KNOT WHILE REPAIRING THE DIAPHRAGM, THE NEEDLE DETACHED FROM THE THREAD WHEN THE SURGEON TRIED PULLING THE SUTURE TO CHECK FOR BREAKAGE AFTER FINISHING THE CX (SURGERY). THE ISSUE OCCURRED IN THREE SUTURES FROM THE SAME VIAL. THE SURGEON DID NOT TRUST THE KNOTS AND OPTED TO START FROM SCRATCH USING A COMPETITOR'S SUTURE TO RESOLVE THE ISSUE. THIS LED TO 30 MINUTES OR MORE EXTENDED SURGICAL TIME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19445176 ↗
• InjuryApr 10, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE NEEDLE BROKE AND FELL INTO THE CAVITY. A NEW NEEDLE WAS USED TO COMPLETE THE CASE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7419444 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K934738. One submission often covers many models, so check the product and lot details in each record.

• Z-2281-2026 · Apr 15, 2026 · Open, Classified
  Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
• Z-2543-2017 · May 3, 2017 · Terminated
  Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO STITCH POLYSORB 2/0 48" U/D DLU