WECK IPN028130Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 34026704625216), received between Feb 9, 2021 and May 20, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2024Break; Break

  IT WAS REPORTED " CLIP WAS FOUND BROKEN DURING USAGE ON THE PATIENT". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354567 ↗
• InjuryMay 1, 2024Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT "FOLLOWING SURGICAL INTERVENTION WITH TERMINAL ILEOSTOMY, UPON AWAKENING THE PATIENT WAS IN HEMORRHAGIC SHOCK WITH ACUTE ANEMIA. WE PROCEED WITH THE EMERGENCY RELAPAROTOMY FINDING ACTIVE ARTERIAL BLEEDING OF THE ILEOCOLIC PEDUNCLE AT THE LEVEL OF THE WELL POSITIONED AND WELL CLOSED HEM-O-LOCK CLIPS. WE PROCEED WITH SUTURING WITH A TRANSFIXED STITCH OF "PROLENE" SUTURE, WITHOUT REMOVE THE HEM-O-LOCK, ACHIEVING COMPLETE HAEMOSTASIS. A REPORT IS SENT FOR A SUSPECTED DEFECT OR MALFUNCTION OF THE MEDICAL DEVICE". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Anemia; Failure to Anastomose; Hypovolemia

  MAUDE report 19226120 ↗
• MalfunctionJan 9, 2024Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT "PACKAGE WAS FOUND BROKEN DURING INSPECTION". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18477026 ↗
• MalfunctionJan 9, 2024Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT "PACKAGE WAS FOUND BROKEN DURING INSPECTION". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18476989 ↗
• MalfunctionNov 21, 2023Break; Break

  IT WAS REPORTED THAT "DURING OPEN NEPHRECTOMY SURGERY, THE CLIP BROKE AFTER IT WAS LOCKED". THE CLIP AND ANY FRAGMENTS WERE REMOVED IT THEIR ENTIRETY FROM THE PATIENT. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18185849 ↗
• MalfunctionNov 21, 2023Break; Break

  IT WAS REPORTED THAT "DURING OPEN SPLENECTOMY SURGERY, THE CLIP BROKE AFTER IT WAS LOCKED". THE BROKEN CLIP WAS REMOVED FROM THE PATIENT AND NO PARTS/FRAGMENTS WERE LEFT IN THE PATIENT. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18182285 ↗
• InjuryOct 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REPORTED IN A MEDICAL JOURNAL, THE REPORT STATES, "A 54-YEAR-OLD MAN UNDERWENT A ROBOT-ASSISTED RADICAL PROSTATECTOMY FOR PROSTATE CANCER ON JUNE 2014. HE HAD BEEN FINE AFTER THE OPERATION, BUT URINARY FREQUENCY AND HEMATURIA OCCURRED AFTER 3 MONTHS. A 7 MM STONE SHADOW WAS FOUND IN THE BLADDER BY ULTRASOUND AND CT SCAN, AND A NON-MOBILE STONE WAS FOUND AT THE 9 O'CLOCK POSITION AT THE VESICOURETHRAL ANASTOMOSIS BY CYSTOSCOPY. THE PATIENT WAS DIAGNOSED AS A BLADDER STONE AND TRANSURETHRAL BLADDER LITHOTRIPSY WAS PERFORMED. WHEN THE SURFACE OF THE STONE WAS CRUSHED, THE CLIP THAT HAD BEEN USED DURING THE RADICAL PROSTATECTOMY APPEARED FROM INSIDE. THE CLIP WAS REMOVED WITH FORCEPS, ALL STONES WERE CRUSHED AND REMOVED, AND THE SURGERY WAS COMPLETED. THE PATIENT HAS BEEN FINE AFTER THE SURGERY AND NO MIGRATION OF THE CLIP HAS BEEN OBSERVED AFTER THAT". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17998020 ↗
• MalfunctionFeb 9, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING THE LOADING OF THE CLIPS ON THE APPLIER THE CLIP WAS NOT HOLDING PROPERLY ON THE APPLIER. IT IS UNKNOWN IF THE ISSUE CAME FROM THE CLIP OR THE APPLIER. THE ISSUE WAS OBSERVED BEFORE USING THE DEVICE ON THE PATIENT. ADDITIONAL INFORMATION: 2 CLIPS FROM THE CARTRIDGE WERE NOT PROPERLY HELD BY THE APPLIER. THESE ARE NOT AVAILABLE FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11304911 ↗