LAPRA-TY XC200Recalls & reported problems

Summary

The FDA's MAUDE database contains 791 adverse event reports that list this exact device (DI 10705031206885), received between Dec 11, 2017 and Sep 30, 2026 — classified as 3 injuries, 788 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (730 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 791 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Positioning Failure

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture clip was used. The clip could not be loaded into an applier properly. The clip could not be deployed. Another device was used to complete the case. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944744 ↗
• MalfunctionSep 30, 2026Positioning Failure

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture clip was used. The clip could not be loaded into an applier properly. The clip could not be deployed. Another device was used to complete the case. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944718 ↗
• MalfunctionSep 30, 2026Positioning Failure

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture clip was used. The clip could not be loaded into an applier properly. The clip could not be deployed. Another device was used to complete the case. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944706 ↗
• MalfunctionSep 29, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936093 ↗
• MalfunctionSep 28, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921945 ↗
• MalfunctionSep 28, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921805 ↗
• MalfunctionSep 28, 2026Positioning Failure

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture clips was used. The clips did not close properly during procedure. Used 4 packs from same lot. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921721 ↗
• MalfunctionSep 28, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921588 ↗
• MalfunctionSep 25, 2026Positioning Failure

  It was reported by a sales rep that, during an unknown surgery, the clip could be loaded into an applier properly three packs in a row, but the clip was not fed into the jaws properly. Same device was used to complete the case. There were no adverse consequences to the patient. No device will be returning. No further information is available. Affiliate Reference Number: (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896997 ↗
• MalfunctionSep 25, 2026Positioning Failure

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. During surgery, the clip could be loaded into an applier properly three packs in a row, but the clip was not fed into the jaws properly. Same device was used to complete the case. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896780 ↗
• MalfunctionSep 17, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809530 ↗
• MalfunctionSep 17, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809526 ↗
• MalfunctionAug 17, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50285370 ↗
• MalfunctionAug 17, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50285345 ↗
• MalfunctionMay 29, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PARTIAL NEPHRECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE CLIPS WERE USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT TO THE SALES REP THAT DURING A PARTIAL NEPHRECTOMY PROCEDURE, THE CLIPS WERE STUCK IN THE HOLDER, THEY COULDN'T GET THEM OUT OF THE CARTRIDGE. NO PATIENT CONSEQUENCES REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25330636 ↗
• MalfunctionMay 29, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PARTIAL NEPHRECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE CLIPS WERE USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT TO THE SALES REP THAT DURING A PARTIAL NEPHRECTOMY PROCEDURE, THE CLIPS WERE STUCK IN THE HOLDER, THEY COULDN'T GET THEM OUT OF THE CARTRIDGE. NO PATIENT CONSEQUENCES REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25330632 ↗
• MalfunctionMay 11, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SACROCOLPOPEXY PROCEDURE ON (B)(6)2026 AND SUTURE CLIPS WERE USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING ROBOT-ASSISTED SACROCOLPOPEXY, THE CLIP COULD NOT BE LOADED INTO AN APPLIER PROPERLY, AND THE CLIP COULD NOT BE FORMED PROPERLY AFTER THAT. THERE IS NO ACTUAL PRODUCT, ONLY THE OUTER BOX WAS RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143115 ↗
• MalfunctionMay 6, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UROLOGICAL PROCEDURE ON (B)(6) 2026 AND SUTURE CLIPS WERE USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN UROLOGICAL SURGERY, WHEN THE DEVICE WAS ATTEMPTED TO USE AS USUAL WAY, THE LAPRA-TY COULD NOT PERFORM LIGATION PROPERLY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25097322 ↗
• MalfunctionMay 6, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE CLIPS WERE USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING ROBOT-ASSISTED RADICAL PROSTATECTOMY, XC200 WAS LOADED INTO THE APPLIER AND CLIPPED TO THE SUTURE, BUT THE RATCHET OF THE CLIPS DID NOT LOCK AND FELL OFF. THIS ISSUE CONTINUED WITH TWO PACKAGES IN A ROW IN THIS ONE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093435 ↗
• MalfunctionMay 6, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE CLIPS WERE USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING ROBOT-ASSISTED RADICAL PROSTATECTOMY, XC200 WAS LOADED INTO THE APPLIER AND CLIPPED TO THE SUTURE, BUT THE RATCHET OF THE CLIPS DID NOT LOCK AND FELL OFF. THIS ISSUE CONTINUED WITH TWO PACKAGES IN A ROW IN THIS ONE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093434 ↗
• MalfunctionMay 5, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE CLIPS WERE USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, WHEN THE HOSPITAL ATTEMPTED TO CONNECT THE CLIPS BY THE APPLIER, IT WAS FOUND THAT THE CLIP IN THE CLIP CARTRIDGE WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE XC200 CARTRIDGE WAS RECEIVED EMPTY, ALONG WITH THE CLIPS BROKEN INSIDE OF A PLASTIC JAR. IN ADDITION, THE FOIL WAS EXAMINED AND SHOWED MULTIPLE WRINKLES AND SMALL HOLES ON THE BOTTOM CAVITY OF THE FOIL PACKAGE RELATED POSSIBLY TO EXCESSIVE MANIPULATION. NO FURTHER INFORMATION IS AVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083714 ↗
• MalfunctionMay 4, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE CLIPS WERE USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING ROBOTIC PROSTATECTOMY, THE DEVICE COULD NOT CLAMP STRATAFIX. ALTHOUGH THE CLIPS WERE REPLACED, THE DEVICE STILL COULD NOT CLAMP, SO ANOTHER PACKAGE WAS TAKEN OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25070373 ↗
• MalfunctionApr 14, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DURING ROBOT-ASSISTED PANCREATICODUODENECTOMY FOR PANCREATIC CANCER PROCEDURE ON (B)(6) 2026 AND SUTURE CLIPS WERE USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING ROBOT-ASSISTED PANCREATICODUODENECTOMY FOR PANCREATIC CANCER, THE CLIP COULD NOT BE LOADED INTO THE APPLIER PROPERLY. ADDITIONALLY, UNFORMED CLIP OCCURRED. THE PRODUCT WAS USED ON THE VASCULAR. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24872239 ↗
• MalfunctionApr 2, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN UROLOGIC SURGERY, ALTHOUGH THE HOSPITAL ATTEMPTED SEVERAL TIMES, CLIPPING TO THE SUTURE COULD NOT BE DONE. THIS ISSUE OCCURRED CONSTANTLY WITH THE SAME LOT NUMBER. ANOTHER COMPETITIVE DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769049 ↗
• MalfunctionApr 2, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN UROLOGIC SURGERY, ALTHOUGH THE HOSPITAL ATTEMPTED SEVERAL TIMES, CLIPPING TO THE SUTURE COULD NOT BE DONE. THIS ISSUE OCCURRED CONSTANTLY WITH THE SAME LOT NUMBER. ANOTHER COMPETITIVE DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24768940 ↗